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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 the last 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 the last study injection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 176 (7 days after the last 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
105 Previous Clinical Trials
61,366,794 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this experiment?

"Indeed, the information accessible on clinicaltrials.gov confirms that this medical study is searching for participants. It was initially published on November 7th 2022 and recently updated on November 10th 2022. This trial seeks to enrol 770 patients from 49 various locations."

Answered by AI

Is it possible to sign up as a participant in this clinical trial?

"This medical study, which plans to welcome 770 participants, is looking for individuals between the ages of 9 and 25 who have contracted cytomegalovirus (CMV)."

Answered by AI

What is the current enrolment for this experimental trial?

"Affirmative. Clinicaltrials.gov has information that confirms this medical trial is still seeking participants, which was initially posted on November 7th 2022 and modified recently on the 10th of November. To proceed with the research, 770 volunteers need to be recruited from 49 distinct sites."

Answered by AI

Is the maximum age for eligibility in this trial set at 45 years old?

"This experiment has a strict age range, as the minimum enrollment is 9 years old and patients must not exceed 25."

Answered by AI

How many healthcare facilities are executing this research experiment?

"A total of 49 clinical trial sites are active, featuring organisations such as Clinical Neurosciences Solutions Inc. (Orlando-East South St) in Orlando, Albuquerque Clinical Trials Inc - Clinedge - PPDS in Albuquerque and JBR Clinical Research - CenExel JBR - PPDS in Salt Lake City amongst other locations."

Answered by AI
~373 spots leftby Jun 2025