mRNA Vaccine for Cytomegalovirus (CMV)

Phase 2

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT.

Be between 18 and 65 years old

Must not have

Receipt of any CMV vaccine other than mRNA-1647.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the long-term effects of the mRNA-1647 vaccine on CMV-negative and CMV-positive adults.

Who is the study for?

This trial is for adults who participated in a prior CMV vaccine study (mRNA-1647-P202) and received the mRNA-1647 vaccine, not placebo. They must have completed that study, be in good health as judged by the investigator, understand and agree to follow trial procedures, and provide written consent. Those previously vaccinated with any CMV vaccine other than mRNA-1647 or with conditions affecting safety assessments or adherence to procedures cannot join.

What is being tested?

The focus of this extension study is on evaluating how long the immune response lasts from the mRNA-1647 vaccine given to both CMV-seronegative and CMV-seropositive adults. It's a continuation for participants who were part of an earlier phase where they received this experimental vaccine against Cytomegalovirus.

What are the potential side effects?

While specific side effects are not listed here, typical reactions to vaccines can include temporary pain at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Any new or unexpected issues will be closely monitored due to the investigational nature of mRNA-1647.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was CMV negative at my initial and final study visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received any CMV vaccine except for mRNA-1647.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Primary Extension PhaseExperimental Treatment1 Intervention

CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.

Group II: Optional Booster Phase - Observational GroupExperimental Treatment1 Intervention

Participants who opted to enroll into the Observational Group will be followed in the optional BP until BP Month 12.

Group III: Optional Booster Phase - BD RecipientsExperimental Treatment1 Intervention

Participants who opted to enroll into the optional Booster Dose phase will receive a single mRNA-1647 vaccine dose.

0 / 2Eligibility criteria met