SARS-CoV-2Phase 3NCT04860297

A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants

A Phase 3 study testing mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
What is being tested?: mRNA-1273
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 15 sitesUnited States
Study dates: 16 Apr 2021to 22 May 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is either a kidney or a liver transplant recipient who is at least 90 days after transplantation at the time of consent, and is either unvaccinated or previously vaccinated with 2 doses of Moderna COVID-19 vaccine who is at least 1 month after the second dose at the time of consent. Participants who received the 2 doses of Moderna COVID-19 vaccine before transplant are not eligible.
Understands, agrees, and is able to comply with the study procedures and provides written informed consent.
Received chronic immunosuppressive therapy for the prevention of allograft rejection for a minimum of 90 days before signing consent, including but not limited to: glucocorticoids (such as, prednisolone), immunophilin binding agents (such as, calcineurin inhibitors, mTOR inhibitors), or inhibitors of de novo nucleotide synthesis (such as, mycophenolic acid, mizoribine, leflunomide, azathioprine).
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second dose (Day 29) for those receiving 2-dose regimen and, through 3 months following the third dose (Day 85) for those receiving 3-dose regimen, and through 3 months following the third dose (Day 1) for those previously vaccinated SOT participants, and not currently breastfeeding.
Is medically stable, according to investigator's judgment, during the 3 months before signing consent.
In good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent, and has not been vaccinated with any COVID-19 vaccine at the time of consent.

Show all 11Show fewer

Understands, agrees, and is able to comply with the study procedures and provides written informed consent.
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1), agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29), and not currently breastfeeding.
Is medically stable, according to investigator's judgment, during the 3 months before signing consent.
Participants must have been previously enrolled in this study (mRNA-1273-P304), are actively participating in Part A, and at least 4 months from the last dose; or participant is either a kidney or a liver SOT recipient who is at least 90 days after transplantation at the time of consent and who completed primary vaccination series (3 doses for mRNA COVID-19 vaccine; 2 doses for non-mRNA COVID-19 vaccine or at least 1 dose of non-mRNA combined with 1 dose of mRNA COVID-19 vaccine) under the EUA who are at least 4 months from the last dose. All primary COVID-19 vaccination series must be completed after transplant.
Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (booster dose Day 1).

Who cannot join

Has prior or planned administration of a coronavirus vaccine (for example, SARS-CoV-2 [for unvaccinated participants only], SARS-CoV, or MERS [Middle East Respiratory Syndrome] -CoV vaccine).
Has current treatment with investigational agents for either prophylaxis against COVID-19 (for unvaccinated participants only) or treatment of COVID-19 (such as, anti-SARS-CoV-2 monoclonal antibodies).
A history of more than one solid organ transplanted (such as, kidney and pancreas). A history of previous kidney or liver transplant is acceptable.
Has received therapies that have depleting properties on T cells, B cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [ATG], monoclonal antibodies, and proteosome inhibitors) within the last 3 months prior to enrollment.
A history of biopsy-proven T-cell- or Ab-mediated rejection within 3 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment.
Has a known close contact with anyone with laboratory confirmed SARS-CoV-2 infection within 2 weeks to vaccine administration or known history of SARS-CoV-2 infection or positive SARS-CoV-2 test.

Show all 27Show fewer

Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
Has a history of clinically relevant donor-specific Ab.
Has a history of complications of immunosuppression
Suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment
Known human immunodeficiency virus (HIV) infection
Has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
Received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.
Healthy Participants
Has a known close contact with anyone with laboratory confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration or known history of SARS-CoV-2 infection or positive SARS-CoV-2 test.
Has prior or planned administration of a coronavirus vaccine (for example, SARS-CoV-2, SARS-CoV, or MERS-CoV vaccine).
Has current treatment with investigational agents for either prophylaxis against COVID-19 or treatment of COVID-19 (for example, anti-SARS-CoV-2 monoclonal antibodies).
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
Has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
Received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 mg/day of prednisone equivalent).
Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.
prior or planned administration of a coronavirus vaccine and current treatment with investigational agents for either prophylaxis against COVID-19.
known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration or any known history of SARS-CoV-2 infection or positive SARSCoV-2 test will apply only to new SOT participants who will be enrolled in Part B.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Piedmont Transplant Institute
Atlanta, Georgia, 30309
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic Hospital
Cleveland, Ohio, 44195
Northwell Health
Manhasset, New York, 11030
Aventiv Research Inc
Mesa, Arizona, 85206
Yale University School of Medicine
New Haven, Connecticut, 06519
Colombia University Medical Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02903
California Institute of Renal Research
San Diego, California, 92123
University of Washington Medical Center
Seattle, Washington, 98195
Tampa General Medical Group
Tampa, Florida, 33606
University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls

This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Conditions: SARS-CoV-2
Being tested: mRNA-1273
Keywords: mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings: Coronavirus Infections, Virus Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mRNA-1273Biological
Sterile liquid for injection

Study groups in NCT04860297
Study group	Role	What they receive
mRNA-1273	Experimental	Part A: All participants (healthy participants and SOT participants) who were unvaccinated prior to enrollment will receive 2 intramuscular (IM) injections of 100 microgram (µg) mRNA-1273 on Day 1 and Day 29. All SOT participants who were unvaccinated prior to enrollment will be offered the opportunity to receive a third primary dose of mRNA-1273 at Day 85 as per the emergency use authorization (EUA) Fact Sheet available at the time of protocol finalization. SOT participants who were previously vaccinated with 2 doses of Moderna COVID-19 vaccine under the EUA prior to enrollment will receive Dose 3 on Day 1. Part B: All eligible participants from Part A will be offered to receive a 100 µg booster dose of mRNA-1273 who are at least 4 months from the last dose. SOT recipients who completed primary COVID-19 vaccination series under EUA (outside of the mRNA-1273-P304 study) will receive a 100 µg booster dose on booster dose Day 1. Receives: Biological: mRNA-1273

What is being measured

The primary outcome is the main question the study is designed to answer.

Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was any AE reported by the participant that was not specified as a solicited adverse reaction (AR) or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Up to 28 days post-vaccination
Parts A and B: Number of Healthy Participants With Unsolicited AEs
An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Up to 28 days post-vaccination
Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)
An MAAE was an AE that led to an unscheduled visit to an healthcare practitioner (HCP). This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With MAAEs
An MAAE was an AE that led to an unscheduled visit to an HCP. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs)
An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With SAEs
An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis
An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With AESIs, Including Myocarditis/Pericarditis
An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Adjudicated Biopsy-Proven Organ Rejection
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With Biopsy-Proven Organ Rejection
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 7 days post-vaccination
Parts A and B: Number of Healthy Participants With Solicited Local and Systemic ARs
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 7 days post-vaccination
Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants
The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay (PsVNA) specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 arbitrary units (AU)/milliliter (mL). The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Measured: Day 57 (for unvaccinated participants)
Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3
The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation.
Measured: 28 days after Dose 3
Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series
The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation.
Measured: 28 days after BD injection (BD-Day 29)

Secondary outcomes (15)

Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated Participants Receiving the 2-Dose Regimen
The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2.
Measured: Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Measured: 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3
Part A: GMFR of nAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2.
Measured: 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMFR of nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Measured: 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3
Part A: Geometric Mean (GM) Value of Anti-SARS-CoV-2 S-specific Binding Antibody (bAb) for Unvaccinated Participants Receiving the 2-Dose Regimen
The GM level of VAC123 spike antibodies, as measured by MesoScale Discovery (MSD) electrochemiluminescence (ECL) multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2.
Measured: Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GM Value of Anti-SARS-CoV-2 S-specific bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
The GM level of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Measured: 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3
Part A: Geometric Mean Fold-Rise (GMFR) of bAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2.
Measured: 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMFR of bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Measured: 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3
Part A: Number of SOT Participants With Asymptomatic SARS-CoV-2 Infection
Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR) central or local test or serology test as binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Part A: Number of Healthy Participants With Asymptomatic SARS-CoV-2 Infection
Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR1) central or local test or serology test as bAb level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Part A: Number of SOT Participants With the Occurrence of COVID-19
COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38 degree celsius [°C]/≥ 100.4 degree fahrenheit [°F]), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Part A: Number of Healthy Participants With the Occurrence of COVID-19
COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38°C/≥ 100.4°F), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Part A: Number of SOT Participants With the Occurrence of Severe COVID-19
Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Part A: Number of Healthy Participants With the Occurrence of Severe COVID-19
Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: 14 days after second and third injection
Parts A and B: Number of SOT Participants Who Changed Immunosuppressant Therapy
A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Measured: Throughout the study period (up to Day 450)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 202122 May 2023

First posted26 Apr 2021
Study start16 Apr 2021
Primary completion22 May 2023
Study completion22 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2Studies of the same condition, open and under way.
More trials run by ModernaTX, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: This is an open-label, single intervention study; there is no randomization
Masking: None (open label)
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04860297
Sponsor's protocol ID: mRNA-1273-P304
Status last verified: May 2024
First submitted: 21 Apr 2021
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Girard B, Figueroa AL, De Rosa SC, McElrath MJ, Azzi JR, Stolman D, Siangphoe U, de Windt E, Miller JM, Das R, Priddy F. mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients. Front Immunol. 2025 Apr 3;16:1505871. doi: 10.3389/fimmu.2025.1505871. eCollection 2025.
PubMed 40248714
Figueroa AL, Azzi JR, Eghtesad B, Priddy F, Stolman D, Siangphoe U, Leony Lasso I, de Windt E, Girard B, Zhou H, Miller JM, Das R. Safety and Immunogenicity of the mRNA-1273 Coronavirus Disease 2019 Vaccine in Solid Organ Transplant Recipients. J Infect Dis. 2024 Sep 23;230(3):e591-e600. doi: 10.1093/infdis/jiae140.
PubMed 38513368

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All SARS-CoV-2 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls
ClinicalTrials.gov ID: NCT04860297
Acronym / sponsor ID: mRNA-1273-P304
Conditions: SARS-CoV-2
Keywords: mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: ModernaTX, Inc.Industry (pharma, biotech, devices)
Study start: 16 Apr 2021 (actual)
Primary completion: 22 May 2023 (actual)
Study completion: 22 May 2023 (actual)
First posted: 26 Apr 2021 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is an open-label, single intervention study; there is no randomization

Arm	Type	Receives
mRNA-1273	Experimental	Biological: mRNA-1273Part A: All participants (healthy participants and SOT participants) who were unvaccinated prior to enrollment will receive 2 intramuscular (IM) injections of 100 microgram (µg) mRNA-1273 on Day 1 and Day 29. All SOT participants who were unvaccinated prior to enrollment will be offered the opportunity to receive a third primary dose of mRNA-1273 at Day 85 as per the emergency use authorization (EUA) Fact Sheet available at the time of protocol finalization. SOT participants who were previously vaccinated with 2 doses of Moderna COVID-19 vaccine under the EUA prior to enrollment will receive Dose 3 on Day 1. Part B: All eligible participants from Part A will be offered to receive a 100 µg booster dose of mRNA-1273 who are at least 4 months from the last dose. SOT recipients who completed primary COVID-19 vaccination series under EUA (outside of the mRNA-1273-P304 study) will receive a 100 µg booster dose on booster dose Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Is either a kidney or a liver transplant recipient who is at least 90 days after transplantation at the time of consent, and is either unvaccinated or previously vaccinated with 2 doses of Moderna COVID-19 vaccine who is at least 1 month after the second dose at the time of consent. Participants who received the 2 doses of Moderna COVID-19 vaccine before transplant are not eligible.
Understands, agrees, and is able to comply with the study procedures and provides written informed consent.
Received chronic immunosuppressive therapy for the prevention of allograft rejection for a minimum of 90 days before signing consent, including but not limited to: glucocorticoids (such as, prednisolone), immunophilin binding agents (such as, calcineurin inhibitors, mTOR inhibitors), or inhibitors of de novo nucleotide synthesis (such as, mycophenolic acid, mizoribine, leflunomide, azathioprine).
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second dose (Day 29) for those receiving 2-dose regimen and, through 3 months following the third dose (Day 85) for those receiving 3-dose regimen, and through 3 months following the third dose (Day 1) for those previously vaccinated SOT participants, and not currently breastfeeding.
Is medically stable, according to investigator's judgment, during the 3 months before signing consent.

Key exclusion criteria (27 listed)

Has prior or planned administration of a coronavirus vaccine (for example, SARS-CoV-2 [for unvaccinated participants only], SARS-CoV, or MERS [Middle East Respiratory Syndrome] -CoV vaccine).
Has current treatment with investigational agents for either prophylaxis against COVID-19 (for unvaccinated participants only) or treatment of COVID-19 (such as, anti-SARS-CoV-2 monoclonal antibodies).
A history of more than one solid organ transplanted (such as, kidney and pancreas). A history of previous kidney or liver transplant is acceptable.
Has received therapies that have depleting properties on T cells, B cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [ATG], monoclonal antibodies, and proteosome inhibitors) within the last 3 months prior to enrollment.
A history of biopsy-proven T-cell- or Ab-mediated rejection within 3 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mRNA-1273Sterile liquid for injection	Biological	mRNA-1273

Primary outcome

Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days post-vaccination
An unsolicited AE was any AE reported by the participant that was not specified as a solicited adverse reaction (AR) or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With Unsolicited AEs
Time frame: Up to 28 days post-vaccination
An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)
Time frame: Throughout the study period (up to Day 450)
An MAAE was an AE that led to an unscheduled visit to an healthcare practitioner (HCP). This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With MAAEs
Time frame: Throughout the study period (up to Day 394)
An MAAE was an AE that led to an unscheduled visit to an HCP. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs)
Time frame: Throughout the study period (up to Day 450)
An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With SAEs
Time frame: Throughout the study period (up to Day 394)
An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis
Time frame: Throughout the study period (up to Day 450)
An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With AESIs, Including Myocarditis/Pericarditis
Time frame: Throughout the study period (up to Day 394)
An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
Time frame: Throughout the study period (up to Day 450)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
Time frame: Throughout the study period (up to Day 394)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With Adjudicated Biopsy-Proven Organ Rejection
Time frame: Throughout the study period (up to Day 450)
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With Biopsy-Proven Organ Rejection
Time frame: Throughout the study period (up to Day 394)
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of SOT Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: 7 days post-vaccination
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Parts A and B: Number of Healthy Participants With Solicited Local and Systemic ARs
Time frame: 7 days post-vaccination
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants
Time frame: Day 57 (for unvaccinated participants)
The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay (PsVNA) specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 arbitrary units (AU)/milliliter (mL). The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons.
Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3
Time frame: 28 days after Dose 3
The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation.
Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series
Time frame: 28 days after BD injection (BD-Day 29)
The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation.

15 secondary outcomes

Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated Participants Receiving the 2-Dose Regimen
Time frame: Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
Time frame: 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3
Part A: GMFR of nAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1
Time frame: 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMFR of nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1
Time frame: 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3
Part A: Geometric Mean (GM) Value of Anti-SARS-CoV-2 S-specific Binding Antibody (bAb) for Unvaccinated Participants Receiving the 2-Dose Regimen
Time frame: Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GM Value of Anti-SARS-CoV-2 S-specific bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen
Time frame: 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3
Part A: Geometric Mean Fold-Rise (GMFR) of bAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1
Time frame: 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2
Part A: GMFR of bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1
Time frame: 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3
Part A: Number of SOT Participants With Asymptomatic SARS-CoV-2 Infection
Time frame: 14 days after second and third injection
Part A: Number of Healthy Participants With Asymptomatic SARS-CoV-2 Infection
Time frame: 14 days after second and third injection
Part A: Number of SOT Participants With the Occurrence of COVID-19
Time frame: 14 days after second and third injection
Part A: Number of Healthy Participants With the Occurrence of COVID-19
Time frame: 14 days after second and third injection
Part A: Number of SOT Participants With the Occurrence of Severe COVID-19
Time frame: 14 days after second and third injection
Part A: Number of Healthy Participants With the Occurrence of Severe COVID-19
Time frame: 14 days after second and third injection
Parts A and B: Number of SOT Participants Who Changed Immunosuppressant Therapy
Time frame: Throughout the study period (up to Day 450)

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A (Primary Series): Cohort A1 - SOT Participants	3	2
Part A (Primary Series): Cohort A2 - SOT Participants	58	57
Part A (Primary Series): Cohort A3 - SOT Participants	71	71
Part A (Primary Series): Cohort A5 - Healthy Participants	20	17
Part B (Booster Dose): Cohort B2 - SOT Participants	0	0
Part B (Booster Dose): Cohort B3 - SOT Participants	0	0
Part B (Booster Dose): Cohort B4 - SOT Participants	0	0
Part B (Booster Dose): Cohort B5 - Healthy Participants	0	0

Primary outcome: Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)

Time frame: Up to 28 days post-vaccination. Count of participants. Unit: Participants

Measure	SOT Kidney Participants n = 137	SOT Liver Participants n = 77	SOT Total n = 214
Value	48	41	89

Population analysed: Safety set included all participants who received at least 1 dose of study drug in this study.

Primary outcome: Parts A and B: Number of Healthy Participants With Unsolicited AEs

Time frame: Up to 28 days post-vaccination. Count of participants. Unit: Participants

Measure	Healthy Participants n = 20
Value	12

Population analysed: Safety set included all participants who received at least 1 dose of study drug in this study.

Primary outcome: Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)

Time frame: Throughout the study period (up to Day 450). Count of participants. Unit: Participants

Measure	SOT Kidney Participants n = 137	SOT Liver Participants n = 77	SOT Total n = 214
Value	86	56	142

Population analysed: Safety set included all participants who received at least 1 dose of study drug in this study.

Primary outcome: Parts A and B: Number of Healthy Participants With MAAEs

Time frame: Throughout the study period (up to Day 394). Count of participants. Unit: Participants

Measure	Healthy Participants n = 20
Value	14

Population analysed: Safety set included all participants who received at least 1 dose of study drug in this study.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 450]). Unsolicited AEs were collected for 28 days after the vaccination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOT Kidney Participants	28 of 137 (20.4%)	49 of 137 (35.8%)	4 of 137
SOT Liver Participants	17 of 77 (22.1%)	38 of 77 (49.4%)	0 of 77
SOT Total	45 of 214 (21%)	87 of 214 (40.7%)	4 of 214
Healthy Participants	1 of 20 (5%)	13 of 20 (65%)	0 of 20

Limitations and caveats (from the sponsor): Healthy participants cohort was included as a control group in the evaluation of humoral and cell-mediated immune response only; no comparisons of safety data with the healthy participants were made.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40248714Girard B, Figueroa AL, De Rosa SC, McElrath MJ, Azzi JR, Stolman D, Siangphoe U, de Windt E, Miller JM, Das R, Priddy F. mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients. Front Immunol. 2025 Apr 3;16:1505871. doi: 10.3389/fimmu.2025.1505871. eCollection 2025.
Derived from this study: PubMed 38513368Figueroa AL, Azzi JR, Eghtesad B, Priddy F, Stolman D, Siangphoe U, Leony Lasso I, de Windt E, Girard B, Zhou H, Miller JM, Das R. Safety and Immunogenicity of the mRNA-1273 Coronavirus Disease 2019 Vaccine in Solid Organ Transplant Recipients. J Infect Dis. 2024 Sep 23;230(3):e591-e600. doi: 10.1093/infdis/jiae140.
Individual participant dataSharing planned: No

Related trials for SARS-CoV-2

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs) (time frame: Up to 28 days post-vaccination). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860297, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.