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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 176 (7 days after each study injection)
Awards & highlights

Study Summary

This trial tests a new vaccine to protect 9-15yo from Cytomegalovirus (CMV). It also compares the vaccine in 16-25yo females to see how well it works.

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 weeks
Treatment ~ Varies
Follow Up ~up to day 176 (7 days after each study injection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 176 (7 days after each study injection) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs
Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)
Number of Medically Attended Adverse Events (MAAEs)
+4 more
Secondary outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,143 Total Patients Enrolled

Media Library

mRNA-1647 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05575492 — Phase 1 & 2
Cytomegalovirus Research Study Groups: mRNA-1647 Dose A, mRNA-1647 Dose B, mRNA-1647 Dose C, Dose Expansion: mRNA-1647, Dose Expansion: Placebo
Cytomegalovirus Clinical Trial 2023: mRNA-1647 Highlights & Side Effects. Trial Name: NCT05575492 — Phase 1 & 2
mRNA-1647 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05575492 — Phase 1 & 2
~298 spots leftby Jun 2025
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