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Virus Therapy

Cytomegalovirus Vaccine for Cytomegalovirus

Phase 1 & 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

Is the participant pregnant?

What is the potential participant’s age?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 527 (end of study)

Summary

This trial tests the safety and effectiveness of the mRNA-1647 vaccine in healthy young people and older females. The vaccine helps the body recognize and fight CMV by teaching it to produce a harmless piece of the virus.

Eligibility Criteria

Inclusion Criteria

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

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Are you pregnant?

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How old is the person who wants to participate?

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The study is only open to certain genders.

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You do not have any underlying health conditions and are generally healthy.

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Can you commit to attending about 12 study visits over a period of 18 months?

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You have received a COVID-19 vaccine or participated in a clinical trial within the past month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 527 (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 527 (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 527 (end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs

Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)

Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies

Secondary study objectives

GMFR of Binding Anti-gB and Anti-pentamer Specific IgG

Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG

Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1647 Dose CExperimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age and 16 to 25 years of age will receive mRNA-1647 at Dose Level C by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Group II: mRNA-1647 Dose BExperimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level B by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Group III: mRNA-1647 Dose AExperimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level A by intramuscular (IM) injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Group IV: Dose Expansion: mRNA-1647Experimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Group V: Dose Expansion: PlaceboPlacebo Group1 Intervention

Participants will receive placebo by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1647

2021

Completed Phase 2

~510

0 / 6Eligibility criteria met