Cytomegalovirus InfectionPhase 2NCT06133010
A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients
A Phase 2 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc..
Trial summary
The purpose of this study is to assess the effect of pre-transplant mRNA-1647 on post-transplant cytomegalovirus (CMV) virologic outcomes, anti-CMV antiviral use, and clinical outcomes in CMV-seropositive and CMV-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- mRNA-1647
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2024to 14 Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a negative (that is, CMV-seronegative) or a positive (that is, CMV-seropositive) result using a blood IgG assay performed at the central laboratory or a previously documented seropositive result.
- Listed and anticipated to receive their first deceased donor or living donor liver transplant within 2 months to 12 months of enrollment.
- A person of nonchildbearing potential, as defined in the protocol.
- 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, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.
Who cannot join
- Listed as "status 1A" for liver transplant.
- Hypersensitivity to acyclovir, ganciclovir, or valganciclovir.
- Previous receipt of a solid organ or hematopoietic transplant.
- Listed for or anticipated to receive an organ transplant other than liver, either simultaneously or sequentially.
- Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.
- Suspected or known allergic reaction to any component of any mRNA vaccine, including mRNA-1647, or its excipients.
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- Human immunodeficiency virus (HIV) infection (based on documented testing performed during the transplant evaluation process and no clinical suspicion of HIV infection).
- Prior (ever) receipt of a stem cell transplant (peripheral blood stem cell, marrow, cord blood).
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Note: Other inclusion and exclusion criteria may apply.
About this study
Official title: A Phase 2, Observer-Blind, Placebo-Controlled, Proof-of-Concept Trial to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients
The purpose of this study is to assess the effect of pre-transplant mRNA-1647 on post-transplant cytomegalovirus (CMV) virologic outcomes, anti-CMV antiviral use, and clinical outcomes in CMV-seropositive and CMV-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity, and immunogenicity of mRNA-1647 in all participants.
- Conditions
- Cytomegalovirus Infection
- Being tested
- mRNA-1647, Placebo
- Keywords
- mRNA-1647, Vaccine, Liver Transplant, CMV, Human Herpesvirus, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Disease, Cytomegalovirus, Virus Disease, Infection Viral, DNA Virus Infections, Messenger RNA
- Medical subject headings
- Cytomegalovirus Infections, Herpes Simplex, Virus Diseases, DNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1647Biological
Sterile liquid for injection
PlaceboBiological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1647 | Experimental | CMV-seronegative and CMV-seropositive participants will receive 3 intramuscular (IM) injections of mRNA-1647 vaccine on Days 1, 29, and 57. Receives: Biological: mRNA-1647 |
| Placebo | Experimental | CMV-seronegative and CMV-seropositive participants will receive 3 IM injections of mRNA-1647 vaccine-matching placebo on Days 1, 29, and 57. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant: Time to the First Occurrence of a Clinically Significant Cytomegalovirus Infection (CS-CMVi) In Seropositive Participants
CS-CMVi will be defined as CMV viremia necessitating treatment (with treatment initiated at viral load ≥250 international units/milliliter [IU/mL] and/or CMV disease) through Day 466.
Measured: Day 373 through Day 466
Number of Participants With Solicited Local and Systemic Adverse Reactions
Measured: Up to Day 64 (7 days after the last study injection)
Number of Participants With Unsolicited Adverse Events
Measured: Up to Day 87 (28 days after the last study injection)
Number of Participants With Medically Attended Adverse Events
Measured: Up to Day 237 (6 months after the last study injection)
Number of Participants With Serious Adverse Events
Measured: Day 1 through Day 542
Number of Participants With Adverse Events of Special Interest
Measured: Day 1 through Day 542
Number of Participants With Adverse Events Leading to Discontinuation
Measured: Day 1 through Day 542
Secondary outcomes (25)
Post-transplant: Time to First Occurrence of Adjudicated CMV Disease in Seronegative Participants Who Receive a Liver Transplant from a CMV-seropositive Donor
Evidence of adjudicated CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence.
Measured: Day 373 through Day 466
Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with Any Occurrence of CMV Viremia
Viremia will be defined as any detectable viral load through Day 466.
Measured: Day 373 through Day 466
Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with an Occurrence of CMV Viremia
Viremia will be defined as a viral load ≥1000 IU/mL through Day 466.
Measured: Day 373 through Day 466
Post-transplant: Duration of anti-CMV Antiviral Therapy
Measured: Day 373 through Day 466
Post-transplant: Time to Initiation of anti-CMV Antiviral Therapy
Measured: Day 373 through Day 466
Post-transplant: Number of Participants Requiring anti-CMV Antiviral Therapy
Measured: Day 373 through Day 466
Number of Participants With Investigator-reported CMV Disease
Evidence of CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence.
Measured: Day 380 through Day 466
Number of Seropositive Participants With CMV Disease, Defined as Adjudicated CMV Disease
Evidence of adjudicated CMV disease and/or infection, as defined in the protocol, will include signs, symptoms, and biopsy evidence. Adjudication will occur by a blinded adjudication committee per protocol.
Measured: Day 380 through Day 466
Post-transplant: Time to Onset of Initial CMV Viremia
Measured: Day 373 through Day 466
Post-transplant: Duration of Initial CMV Viremia
Measured: Day 373 through Day 466
Post-transplant: Number of Participants With Recurrent CMV Viremia Following 2 Consecutive Undetectable CMV Viral Load Assays
Recurrent CMV viremia will be defined as a viral load ≥250 IU/mL for seropositive participants and any detectable level for seronegative participants who receive a seropositive organ.
Measured: Day 373 through Day 466
Post-transplant: Duration of Recurrent CMV Viremia
Recurrent CMV viremia will be defined as a viral load ≥250 IU/mL for seropositive participants and any detectable level for seronegative participants who receive a seropositive organ
Measured: Day 373 through Day 466
Post-transplant: Peak Viral Load in Participants with CMV Viremia
Measured: Day 373 through Day 466
Post-transplant: CMV Viremia Area Under the Curve
Measured: Day 373 through Day 466
Post-transplant: Number of Participants With Neutropenia
Neutropenia will be defined as an absolute neutrophil count ≤500 absolute neutrophils/microliter.
Measured: Day 373 through Day 466
Post-transplant: Number of Participants With Leukopenia on 2 Successive Measurements Separated by at Least 24 Hours
Leukopenia will be defined as an absolute white blood cells (WBC) <3500 cells/cubic milliliter (mm^3) if baseline was ≥4000 cells/mm^3 or a decrease in WBC of >20% if the baseline count was <4000 cells/mm^3.
Measured: Day 365 through Day 466
Post-transplant: Number of Participants Requiring Liver Re-transplantation
Measured: Day 365 through Day 542
Post-transplant: All-cause Mortality
Measured: Day 365 through Day 542
Post-transplant: Number of Participants with Biopsy Proven Allograft Rejection
Biopsy proven allograft rejection will be adjudicated by a blinded adjudication committee per protocol.
Measured: Day 365 through Day 542
Pre-transplant: Titer of CMV- Specific Neutralizing Antibody (nAb) as Measured by Cell-based Neutralization Assay
Measured: Day 1, Day 29, Day 57, Day 87, Day 237, and Day 365
Post-transplant: Titer of CMV-Specific nAb Post-transplant as Measured by Cell-based Neutralization Assay
Measured: Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Titer (GMT) of Anti-glycoprotein B (gB)-specific Immunoglobulin G (IgG) and Antipentamer-specific IgG as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Concentration (GMC) of Anti-gB-specific IgG and Antipentamer-specific IgG as Measured by ELISA
Measured: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Ratio (GMR) of Post-baseline/Baseline GMTs and GMCs
Measured: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline GMTs or GMCs
Measured: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start8 Feb 2024
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
Why it stopped: Trial was cancelled by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133010
- Sponsor's protocol ID
- mRNA-1647-P206
- Status last verified
- Mar 2024
- First submitted
- 10 Nov 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Observer-Blind, Placebo-Controlled, Proof-of-Concept Trial to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients
- ClinicalTrials.gov ID
- NCT06133010
- Acronym / sponsor ID
- mRNA-1647-P206
- Conditions
- Cytomegalovirus Infection
- Keywords
- mRNA-1647, Vaccine, Liver Transplant, CMV, Human Herpesvirus, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was cancelled by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Dec 2027 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of pre-transplant mRNA-1647 on post-transplant cytomegalovirus (CMV) virologic outcomes, anti-CMV antiviral use, and clinical outcomes in CMV-seropositive and CMV-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity, and immunogenicity of mRNA-1647 in all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1647 | Experimental | Biological: mRNA-1647CMV-seronegative and CMV-seropositive participants will receive 3 intramuscular (IM) injections of mRNA-1647 vaccine on Days 1, 29, and 57. |
| Placebo | Experimental | Biological: PlaceboCMV-seronegative and CMV-seropositive participants will receive 3 IM injections of mRNA-1647 vaccine-matching placebo on Days 1, 29, and 57. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a negative (that is, CMV-seronegative) or a positive (that is, CMV-seropositive) result using a blood IgG assay performed at the central laboratory or a previously documented seropositive result.
- Listed and anticipated to receive their first deceased donor or living donor liver transplant within 2 months to 12 months of enrollment.
- A person of nonchildbearing potential, as defined in the protocol.
- 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, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.
Key exclusion criteria (10 listed)
- Listed as "status 1A" for liver transplant.
- Hypersensitivity to acyclovir, ganciclovir, or valganciclovir.
- Previous receipt of a solid organ or hematopoietic transplant.
- Listed for or anticipated to receive an organ transplant other than liver, either simultaneously or sequentially.
- Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.
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-1647Sterile liquid for injection | Biological | mRNA-1647 |
| PlaceboSterile liquid for injection | Biological | Placebo |
Primary outcome
Post-transplant: Time to the First Occurrence of a Clinically Significant Cytomegalovirus Infection (CS-CMVi) In Seropositive Participants
Time frame: Day 373 through Day 466
CS-CMVi will be defined as CMV viremia necessitating treatment (with treatment initiated at viral load ≥250 international units/milliliter [IU/mL] and/or CMV disease) through Day 466.
Number of Participants With Solicited Local and Systemic Adverse Reactions
Time frame: Up to Day 64 (7 days after the last study injection)
Number of Participants With Unsolicited Adverse Events
Time frame: Up to Day 87 (28 days after the last study injection)
Number of Participants With Medically Attended Adverse Events
Time frame: Up to Day 237 (6 months after the last study injection)
Number of Participants With Serious Adverse Events
Time frame: Day 1 through Day 542
Number of Participants With Adverse Events of Special Interest
Time frame: Day 1 through Day 542
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: Day 1 through Day 542
25 secondary outcomes
Post-transplant: Time to First Occurrence of Adjudicated CMV Disease in Seronegative Participants Who Receive a Liver Transplant from a CMV-seropositive Donor
Time frame: Day 373 through Day 466
Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with Any Occurrence of CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: Number of Seronegative Participants Who Received a Liver Transplant from a CMV-seropositive Donor with an Occurrence of CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: Duration of anti-CMV Antiviral Therapy
Time frame: Day 373 through Day 466
Post-transplant: Time to Initiation of anti-CMV Antiviral Therapy
Time frame: Day 373 through Day 466
Post-transplant: Number of Participants Requiring anti-CMV Antiviral Therapy
Time frame: Day 373 through Day 466
Number of Participants With Investigator-reported CMV Disease
Time frame: Day 380 through Day 466
Number of Seropositive Participants With CMV Disease, Defined as Adjudicated CMV Disease
Time frame: Day 380 through Day 466
Post-transplant: Time to Onset of Initial CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: Duration of Initial CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: Number of Participants With Recurrent CMV Viremia Following 2 Consecutive Undetectable CMV Viral Load Assays
Time frame: Day 373 through Day 466
Post-transplant: Duration of Recurrent CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: Peak Viral Load in Participants with CMV Viremia
Time frame: Day 373 through Day 466
Post-transplant: CMV Viremia Area Under the Curve
Time frame: Day 373 through Day 466
Post-transplant: Number of Participants With Neutropenia
Time frame: Day 373 through Day 466
Post-transplant: Number of Participants With Leukopenia on 2 Successive Measurements Separated by at Least 24 Hours
Time frame: Day 365 through Day 466
Post-transplant: Number of Participants Requiring Liver Re-transplantation
Time frame: Day 365 through Day 542
Post-transplant: All-cause Mortality
Time frame: Day 365 through Day 542
Post-transplant: Number of Participants with Biopsy Proven Allograft Rejection
Time frame: Day 365 through Day 542
Pre-transplant: Titer of CMV- Specific Neutralizing Antibody (nAb) as Measured by Cell-based Neutralization Assay
Time frame: Day 1, Day 29, Day 57, Day 87, Day 237, and Day 365
Post-transplant: Titer of CMV-Specific nAb Post-transplant as Measured by Cell-based Neutralization Assay
Time frame: Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Titer (GMT) of Anti-glycoprotein B (gB)-specific Immunoglobulin G (IgG) and Antipentamer-specific IgG as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Concentration (GMC) of Anti-gB-specific IgG and Antipentamer-specific IgG as Measured by ELISA
Time frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Ratio (GMR) of Post-baseline/Baseline GMTs and GMCs
Time frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Pre- and Post-transplant: Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline GMTs or GMCs
Time frame: Day 1, Day 29, Day 57, Day 87, Day 237, Day 365, Day 466, and Day 542
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc..
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Post-transplant: Time to the First Occurrence of a Clinically Significant Cytomegalovirus Infection (CS-CMVi) In Seropositive Participants (time frame: Day 373 through Day 466). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024.