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Virus Therapy

CMV Vaccine for Cytomegalovirus

Phase 3
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
What is the potential participant’s age?
Are you female?
Timeline
Screening 7 days
Treatment 6 months
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new vaccine for CMV, a virus that can cause problems for pregnant women and their babies. The vaccine is being tested for safety and whether it works.

Eligible Conditions
  • Cytomegalovirus

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 7 days
Treatment ~ 6 months
Follow Up ~24 months
This trial's timeline: 7 days for screening, 6 months for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Number of Participants With Solicited Adverse Reactions (ARs)
+2 more
Secondary outcome measures
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1647Experimental Treatment1 Intervention
Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1647
2021
Completed Phase 2
~510

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,370,815 Total Patients Enrolled

Media Library

mRNA-1647 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05085366 — Phase 3
Cytomegalovirus Research Study Groups: mRNA-1647, Placebo
Cytomegalovirus Clinical Trial 2023: mRNA-1647 Highlights & Side Effects. Trial Name: NCT05085366 — Phase 3
mRNA-1647 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085366 — Phase 3
Cytomegalovirus Patient Testimony for trial: Trial Name: NCT05085366 — Phase 3

Frequently Asked Questions

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

Are we still able to enroll individuals in this experiment?

"From what is available on clinicaltrials.gov, this research is still looking for volunteers. The trial was first put up on October 26th 2021 and has since been updated on November 10th 2022."

Answered by AI

Are there any qualifications that participants must meet to be a part of this experimental program?

"Eligibility criteria for this clinical trial state that participants must have a cytomegalovirus infection and be between 16-40 years old. So far, 6900 people have been recruited."

Answered by AI

Is the target age group for this trial 35 years or older?

"This clinical trial only allows patients aged 16-40 to enroll. Out of the 871 total trials, this is one of 218 that excludes patients over 18 and one of 653 that includes patients under 65."

Answered by AI

In how many different hospitals is this trial being run today?

"Patients are currently being recruited for this study at several locations including LMC Manna Research - Toronto - HyperCore - PPDS, Iowa Clinic, and McGill University Health Center. There are also 100 other sites across the world where enrolment is active."

Answered by AI

When might we see mRNA-1647 hit the shelves?

"Based on our internal scoring system, we believe that the mRNA-1647 is safe enough to be given a 3. This is because it has reached Phase 3 clinical trials which means that there is some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

How many patients are currently enrolled in this clinical trial?

"ModernaTX, Inc. is the sponsor of this study that needs 6,900 eligible patients to be conducted across multiple sites - LMC Manna Research - Toronto - HyperCore - PPDS in Toronto, Iowa and Iowa Clinic in Des Moines, Quebec."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
California
Other
How old are they?
18 - 65
What site did they apply to?
ClinOhio Research Services
University of Minnesota Clinical Research Unit
Paradigm Clinical Research Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

When can I start ? How many visits are there? How much of it is in person?
PatientReceived no prior treatments
As of now how long would it be? How long do the screenings take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Wanting to help. I’m an scientist. Because I need to. Need the extra money.
PatientReceived 1 prior treatment
Wondering what it is.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. CVS HealthHub - Savannah: < 24 hours
  2. Foothill Family Clinic - South Clinic: < 24 hours
  3. Meridian Clinical Research (Endwell-New York) - Platinum - PPDS: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
Pediatric Infectious Disease JournalJournal
Congenital Infections: Priorities and Possibilities for Resource-limited Settings
Kadambari, Seilesh, Ceri Evans, and Hermione Lyall. 2022. “Congenital Infections: Priorities and Possibilities for Resource-limited Settings”. Pediatric Infectious Disease Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/inf.0000000000003710.
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
2021. "A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05085366.
~3168 spots leftby Apr 2026
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