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Virus Therapy

mRNA Vaccine for Cytomegalovirus (CMV)

Phase 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
Male or female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will study the long-term effects of the mRNA-1647 vaccine on CMV-negative and CMV-positive adults.

Who is the study for?
This trial is for adults who participated in a prior CMV vaccine study (mRNA-1647-P202) and received the mRNA-1647 vaccine, not placebo. They must have completed that study, be in good health as judged by the investigator, understand and agree to follow trial procedures, and provide written consent. Those previously vaccinated with any CMV vaccine other than mRNA-1647 or with conditions affecting safety assessments or adherence to procedures cannot join.Check my eligibility
What is being tested?
The focus of this extension study is on evaluating how long the immune response lasts from the mRNA-1647 vaccine given to both CMV-seronegative and CMV-seropositive adults. It's a continuation for participants who were part of an earlier phase where they received this experimental vaccine against Cytomegalovirus.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions to vaccines can include temporary pain at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Any new or unexpected issues will be closely monitored due to the investigational nature of mRNA-1647.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was CMV negative at my initial and final study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BP: GMTs of Antigen-Specific nAb and bAb
BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
BP: Number of Participants with Medically-Attended AEs (MAAEs)
+3 more
Secondary outcome measures
Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation
Primary Extension Phase: Number of Participants With SAEs

Trial Design

3Treatment groups
Experimental Treatment
Group I: Primary Extension PhaseExperimental Treatment1 Intervention
CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.
Group II: Optional Booster Phase - Observational GroupExperimental Treatment1 Intervention
Participants who opted to enroll into the Observational Group will be followed in the optional BP until BP Month 12.
Group III: Optional Booster Phase - BD RecipientsExperimental Treatment1 Intervention
Participants who opted to enroll into the optional Booster Dose phase will receive a single mRNA-1647 vaccine dose.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,834 Total Patients Enrolled

Media Library

mRNA-1647 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04975893 — Phase 2
Cytomegalovirus Research Study Groups: Optional Booster Phase - BD Recipients, Primary Extension Phase, Optional Booster Phase - Observational Group
Cytomegalovirus Clinical Trial 2023: mRNA-1647 Highlights & Side Effects. Trial Name: NCT04975893 — Phase 2
mRNA-1647 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975893 — Phase 2

Frequently Asked Questions

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

Can individuals aged eighty-five and older participate in the evaluation?

"This medical investigation seeks individuals between 18 and 40 years old to take part in their study."

Answered by AI

Do I meet the criteria to partake in this examination?

"This particular trial is accepting 291 adults aged 18-40 presenting with cytomegalovirus infections. To be eligible, individuals must comprehend the procedures of this experiment and sign a document consenting to take part in it, have been CMV seronegative at screening for mRNA-1647-P202 or have received an injection of mRNA 1647 as per the randomisation process in Study mRNA-1647 P202 and remain generally healthy enough to comply with all protocols."

Answered by AI

What safeguards have been put in place to ensure the security of patients undergoing this process?

"Although Phase 2 clinical trials have not yet produced efficacy data, there is still some evidence that this treatment presents a safety risk of 2."

Answered by AI

Are there still vacancies available in this research project for participants?

"The latest data on clinicaltrials.gov suggests that this medical trial, initially posted in June 2021, is not currently recruiting candidates; however, there are 790 other studies seeking participants right now."

Answered by AI

What is the scope of facilities conducting this research trial?

"Presently, Tekton Research Inc in Austin, Crossroads Clinical Research (Victoria) in Victoria, and Johnson County Clin-Trials, Inc. in Lenexa are among the 6 recruitment sites for this trial; there are also other locales that have been added to the roster recently."

Answered by AI

Who else is applying?

What site did they apply to?
J. Lewis Research, Inc. / Foothill Family Clinic South
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have CMV and want to learn more and study more of CMV and how to help and prevent CMV.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine
2021. "A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975893.
All > Cmv
~141 spots leftby Dec 2026
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