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SARS-CoV-2Phase 2/3NCT04927065

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants

A Phase 2/3 study testing mRNA-1273.211, mRNA-1273 and mRNA-1273.617.2 in people with SARS-CoV-2, run by ModernaTX, Inc. at 23 sites in United States.

Completed

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

Official record
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Trial summary

This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses. Read more about this study

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-1273.211, mRNA-1273 and mRNA-1273.617.2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,161 participants
Where
23 sitesUnited States
Study dates
28 May 2021to 17 Nov 2023
Phase
Phase 2/3
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

  • 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 Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.
  • Participants must have been either previously enrolled in the mRNA-1273-P301 (COVE) study, must have received 2 doses of mRNA-1273 in that study, with their second dose at least 6 months prior to enrollment in this study (mRNA-1273-P205), and must be currently enrolled and compliant in that study (that is, has not withdrawn or discontinued early); or participant must have received 2 doses of mRNA-1273 under the EUA with their second dose at least 6 months prior to enrollment in mRNA-1273-P205; or have received a 2 dose primary series of mRNA-1273 followed by a 50 μg booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA at least 3 months prior to enrolment in mRNA-1273-P205; and able to provide proof of vaccination status at the time of screening (Day 1); or for enrollment in Part A.2, participant must be currently enrolled and compliant in Part A.1 of the mRNA 1273 P205 study and must have received their first booster dose of mRNA 1273.211 50 μg; or for enrollment in Part J, participant must meet at least 1 of the following criteria: completed enrollment in Part H of the mRNA-1273-P205 study; or received a 2-dose primary series of mRNA-1273 (100 μg) followed by a 50 μg booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA, followed by a 50 μg booster dose of mRNA-1273.222 under EUA at least 3 months prior to enrollment in Part J of mRNA-1273-P205; or previously received a 2-dose primary series of mRNA vaccine against SARS-CoV-2 followed by a booster dose of a monovalent mRNA vaccine, followed by a second booster dose of a bivalent mRNA vaccine. Participants in Part J must also provide proof of vaccination status at the time of screening (Day 0 or Day 1).

Who cannot join

  • Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the US Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.
  • Known history of SARS-CoV-2 infection within 3 months prior to enrollment.
  • Is acutely ill or febrile (temperature ≥38.0°Celsius/[100.4°Fahrenheit]) less than 72 hours prior to or at the Screening Visit (Day 0) or Day 1.
  • 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 received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Known or suspected allergy or history of anaphylaxis, urticaria, or other significant AR to the vaccine or its excipients.
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  • Has a documented history of myocarditis or pericarditis within 2 months prior to Screening Visit (Day 0).
  • Has received or plans to receive any licensed vaccine ≤28 days prior to the injection (Day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
  • Has received systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study.
  • Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study.
  • Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of screening for this study.
  • Note: Other inclusion and exclusion criteria may apply.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Benchmark Research - Austin - HyperCore

    Austin, Texas, 78705

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Meridian Clinical Research-(Baton Rouge, Louisiana)

    Baton Rouge, Louisiana, 70809

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Benchmark Research - Fort Worth - HyperCore

    Fort Worth, Texas, 76135

  • Meridian Clinical Research (Grand Island, Nebraska)

    Grand Island, Nebraska, 68803

  • Research Centers of America

    Hollywood, Florida, 33024

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216

  • Johnson County Clinical Trials

    Lenexa, Kansas, 66219

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Meridian Clinical Research, LLC

    New York, New York, 13901

  • Meridian Clinical Research (Norfolk-Nebraska)

    Norfolk, Nebraska, 68701

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research-(Omaha Nebraska)

    Omaha, Nebraska, 68134

  • Meridian Clinical Research-(Rockville Maryland)

    Rockville, Maryland, 20854

  • Benchmark Research (California)

    Sacramento, California, 95864

  • Meridian Clinical Research-(Savannah Georgia)

    Savannah, Georgia, 31406

  • Meridian Clinical Research (Iowa)

    Sioux City, Iowa, 51106

  • Washington State University

    St Louis, Missouri, 63110

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • DM Clinical Research

    Tomball, Texas, 77375

  • Trial Management Associates

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

Official title: A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants

This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses.

Read the detailed description

This clinical study will consist of 9 parts: A (1 and 2), B, C, D, E, F, G, H, and J.

Part A.1 will evaluate 2 dose levels of the mRNA-1273.211 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE [NCT04470427]) study who have previously received 2 doses of mRNA-1273.

Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273.214 vaccine candidate when administered as a second booster dose to adult participants of the mRNA-1273-P205 study who have previously received 2 doses of mRNA-1273 as a primary series and a first booster of (50 μg total mRNA content) of the mRNA-1273.211 in Part A.1 of this study.

Part B will evaluate the mRNA-1273 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE [NCT04470427]) study who have previously received 2 doses of mRNA-1273.

Part C will evaluate 2 dose levels of the mRNA-1273.617.2 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE [NCT04470427]) study who have previously received 2 doses of mRNA-1273.

Part D will evaluate 2 dose levels of the mRNA-1273.213 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE [NCT04470427]) study who have previously received 2 doses of mRNA-1273.

Part E will be enrolled at a single clinical study site. Part E will evaluate the mRNA-1273.213 vaccine when administered as a single booster dose to adult participants who have previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine, including mRNA-1273.

Part F will consist of 2 cohorts: Cohort 1 will consist of adults who have previously received 2 doses of mRNA-1273 as primary series. Cohort 1 will evaluate the mRNA-1273.529 vaccine as a single booster dose. Cohort 2 will consist of adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273 in study mRNA-1273-P301 (COVE [NCT04470427]) or under the emergency use authorization (EUA). Cohort 2 will evaluate the mRNA-1273.529 and mRNA-1273 vaccines as a single booster dose.

Part G will evaluate the mRNA1273.214 vaccine candidate when administered as a second booster dose to adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273.

Part H will evaluate the immunogenicity, safety, and reactogenicity of the mRNA- 1273.222 vaccine candidate when administered as a second booster dose to adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273.

Part J will evaluate mRNA-1273.815 and mRNA-1273.231 when administered as a booster dose to adults who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-COV-2.

Conditions
SARS-CoV-2
Being tested
mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529
Keywords
mRNA-1273, mRNA-1273 vaccine, mRNA-1273.211, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.815, mRNA-1273.231, 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-1273.211Biological

    Sterile liquid for injection

  • mRNA-1273Biological

    Sterile liquid for injection

  • mRNA-1273.617.2Biological

    Sterile liquid for injection

  • mRNA-1273.213Biological

    Sterile liquid for injection

  • mRNA-1273.529Biological

    Sterile liquid for injection

  • mRNA-1273.214Biological

    Sterile liquid for injection

  • mRNA-1273.222Biological

    Sterile liquid for injection

  • mRNA-1273.815Biological

    Sterile liquid for injection

  • mRNA-1273.231Biological

    Sterile liquid for injection

Study groups in NCT04927065
Study groupRoleWhat they receive
Part A.1: mRNA-1273.211 50 μgExperimentalParticipants will receive 1 intramuscular booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1.
Receives: Biological: mRNA-1273.211
Part A.1: mRNA-1273.211 100 μgExperimentalParticipants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.211 on Day 1.
Receives: Biological: mRNA-1273.211
Part B: mRNA-1273 100 μgExperimentalParticipants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273 on Day 1.
Receives: Biological: mRNA-1273
Part C: mRNA-1273.617.2 100 μgExperimentalParticipants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.617.2 on Day 1.
Receives: Biological: mRNA-1273.617.2
Part C: mRNA-1273.617.2 50 μgExperimentalParticipants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.617.2 on Day 1.
Receives: Biological: mRNA-1273.617.2
Part D: mRNA-1273.213 50 μgExperimentalParticipants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.213 on Day 1.
Receives: Biological: mRNA-1273.213
Part D: mRNA-1273.213 100 μgExperimentalParticipants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Receives: Biological: mRNA-1273.213
Part E: mRNA-1273.213 100 μgExperimentalParticipants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Receives: Biological: mRNA-1273.213
Part F Cohort 1: mRNA-1273.529 50 μgExperimentalParticipants will receive 1 intramuscular first booster dose of 50 μg of mRNA-1273.529 on Day 1.
Receives: Biological: mRNA-1273.529
Part F Cohort 2: mRNA-1273.529 50 μg and mRNA-1273 50 μgExperimentalParticipants will receive 1 intramuscular second booster dose of 50 μg of mRNA-1273.529 or mRNA-1273 enrolled sequentially (after receiving a primary series of mRNA-1273 and a single booster dose of mRNA-1273 50 μg) on Day 1.
Receives: Biological: mRNA-1273; Biological: mRNA-1273.529
Part G: mRNA-1273.214 50 μgExperimentalParticipants will receive 1 intramuscular second booster dose of mRNA-1273.214 50 μg on Day 1.
Receives: Biological: mRNA-1273.214
Part A.2: mRNA-1273.214 50 μgExperimentalParticipants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.214 on Day 1.
Receives: Biological: mRNA-1273.214
Part H: mRNA-1273.222 50 μgExperimentalParticipants will receive 1 intramuscular second booster dose of 50 μg of mRNA-1273.222 on Day 1.
Receives: Biological: mRNA-1273.222
Part J: mRNA-1273.815 or mRNA-1273.231ExperimentalParticipants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.815 or 50 ug of mRNA-1273.231 on Day 1.
Receives: Biological: mRNA-1273.815; Biological: mRNA-1273.231

What is being measured

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

  1. Number of Participants With Solicited Local and Systemic ARs

    Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. The Investigator reviewed whether the solicited AR was also to be recorded as an adverse event (AE). A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

    Measured: 7 days post-vaccination

  2. Number of Participants With Unsolicited AEs

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

    Measured: Up to 28 days post-vaccination

  3. Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation

    An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (EOS) are reported in this outcome measure.

    Measured: Day 1 to EOS (Day 366 for Parts A.1, B, C, D, E, and F; and Day 181 for Parts A.2, H, and J)

  4. Geometric Mean Titer (GMT) of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral severe acute respiratory syndrome coronavirus (SARS-CoV-2) (D614G) at Day 29 is reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 arbitrary units (AU)/milliliter (mL) and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  5. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 is reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  6. Seroresponse Rate (SRR) (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  7. SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  8. SRR (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  9. SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  10. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) at Day 29 is reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 29

  11. SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 29

  12. SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 29

  13. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 is reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  14. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 91 is reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 91

  15. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 29

  16. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 29

  17. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 91 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 91

  18. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 91 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Day 91

  19. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    GMT of serum pseudovirus nAb ID50 titers against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 is reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  20. SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  21. SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  22. GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815

    GMT of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the lower limit of detection (LOD) are replaced by 0.5 * LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 15

  23. GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815

    GMT of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 * LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 29

  24. Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815

    GMFR of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 is reported. GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 * LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 15

  25. GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815

    GMFR of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 is reported. GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 * LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5

    Measured: Day 29

  26. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 15 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 15

  27. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 15 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 15

  28. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 29

  29. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 29

Secondary outcomes (14)

  1. GMT of Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    GMT of serum pseudovirus nAb ID50 titers against ancestral SARS-CoV-2 (D614G) at Day 29 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  2. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  3. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 29

  4. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Days 29, 91, 181, and 366

  5. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Days 29, 91, 181, and 366

  6. GMT of Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)

    GMT of serum pseudovirus nAb ID50 titers against BA.4/BA.5 at Day 181 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 181

  7. GMT of Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    GMT of serum pseudovirus nAb ID50 titers against ancestral SARS-CoV-2 (D614G) at Day 181 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  8. SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 181

  9. SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  10. SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.

    Measured: Day 181

  11. SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Day 181

  12. SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Days 181 and 366

  13. SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.

    Measured: Days 181 and 366

  14. GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) on Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

    GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) on Days 181 and 366 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.

    Measured: Days 181 and 366

Timeline

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

  1. First posted15 Jun 2021
  2. Study start28 May 2021
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 2023

Resources

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 2/3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Parts A-H: Sequential Part J: Parallel (participants were randomized to receive either mRNA-1273.815 or mRNA-1273.231)
Masking
None (open label)
Enrolment
5,161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927065
Sponsor's protocol ID
mRNA-1273-P205
Status last verified
Feb 2025
First submitted
14 Jun 2021
Last updated
28 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chalkias S, Whatley JL, Eder F, Essink B, Khetan S, Bradley P, Brosz A, McGhee N, Tomassini JE, Chen X, Zhao X, Sutherland A, Shen X, Girard B, Edwards DK, Feng J, Zhou H, Walsh S, Montefiori DC, Baden LR, Miller JM, Das R. Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results. Nat Med. 2023 Sep;29(9):2325-2333. doi: 10.1038/s41591-023-02517-y. Epub 2023 Aug 31.

    PubMed 37653342

  • Chalkias S, Harper C, Vrbicky K, Walsh SR, Essink B, Brosz A, McGhee N, Tomassini JE, Chen X, Chang Y, Sutherland A, Montefiori DC, Girard B, Edwards DK, Feng J, Zhou H, Baden LR, Miller JM, Das R. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N Engl J Med. 2022 Oct 6;387(14):1279-1291. doi: 10.1056/NEJMoa2208343. Epub 2022 Sep 16.

    PubMed 36112399

  • Chalkias S, Schwartz H, Nestorova B, Feng J, Chang Y, Zhou H, Dutko FJ, Edwards DK, Montefiori D, Pajon R, Leav B, Miller JM, Das R. Safety and Immunogenicity of a 100 mug mRNA-1273 Vaccine Booster for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). medRxiv [Preprint]. 2022 Mar 7:2022.03.04.22271830. doi: 10.1101/2022.03.04.22271830.

    PubMed 35291289

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing mRNA-1273.211, mRNA-1273 and mRNA-1273.617.2 in people with SARS-CoV-2, run by ModernaTX, Inc. at 23 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 2 inclusion and 12 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Feb 2025). 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?

Number of Participants With Solicited Local and Systemic ARs (time frame: 7 days post-vaccination). The study lists 29 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 NCT04927065, which also lists 3 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 28 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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