mRNA-1647 for Cytomegalovirus

Phase 1

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests the safety and effectiveness of the mRNA-1647 vaccine in healthy Japanese adults aged 18-40, both those who have never had CMV and those who have. The vaccine helps the body recognize and fight CMV by using a small piece of genetic material. The CMV gB vaccine is well-tolerated and highly immunogenic in toddlers.

Eligible Conditions

Cytomegalovirus (CMV)

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1647Experimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule.

Group II: PlaceboPlacebo Group1 Intervention

CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1647

2021

Completed Phase 2

~510

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