← Back to Search

Cancer Vaccine

mRNA-1647 for Cytomegalovirus

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 29, day 56, day 84, day 168, day 196, day 336, and day 504

Awards & highlights

Study Summary

This trial will study the effects of a new CMV vaccine in healthy adults, aged 18-40. It will test for safety and how well the vaccine works.

Eligible Conditions

Cytomegalovirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 29, day 56, day 84, day 168, day 196, day 336, and day 504

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 29, day 56, day 84, day 168, day 196, day 336, and day 504

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, day 56, day 84, day 168, day 196, day 336, and day 504 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection

Frequency of Medically-Attended Adverse Events (MAAEs)

Frequency of Serious Adverse Events (SAEs)

+3 more

Secondary outcome measures

Change from Baseline in Associated GMR of Anti-gB Specific IgG and Anti-Pentamer Specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers

Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups

Change from Baseline in GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1647 Dose Level CExperimental Treatment1 Intervention

Participants will receive mRNA-1647 vaccine at Dose Level C by IM injection on Day 1, Day 56, and Day 168.

Group II: mRNA-1647 Dose Level BExperimental Treatment1 Intervention

Participants will receive mRNA-1647 vaccine at Dose Level B by IM injection on Day 1, Day 56, and Day 168.

Group III: mRNA-1647 Dose Level AExperimental Treatment1 Intervention

Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection on Day 1, Day 56, and Day 168.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1647

2021

Completed Phase 2

~510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,379,002 Total Patients Enrolled

Frequently Asked Questions

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

Did the FDA grant permission to market mRNA-1647 yet?

"There is some data attesting to mRNA-1647's security, thus it was graded a 2 on the safety scale. Unfortunately, no evidence exists yet supporting its efficacy."

Answered by AI

Are there a plethora of sites in the U.S. that are conducting this clinical experiment?

"Patients can access this trial at Benchmark Research in Fort Worth, Moderna Clinical Site 1 in Layton and Moderna Clinical Site 2 in Oklahoma City. Additionally, there are 11 other places where recruitment is open."

Answered by AI

Are researchers still recruiting participants for this experiment?

"As per clinicaltrials.gov, this medical study is not presently enrolling patients. Initial posting occurred on September 1st 2020 and the listing was most recently updated in December 2021. Despite that, there are currently 790 other trials actively searching for participants to join their studies."

Answered by AI

Does this research trial include seniors aged 75 or older?

"This clinical trial is recruiting participants aged 18 to 40. There are 205 distinct studies for those under the legal age and 621 separate medical trials available to individuals over 65 years old."

Answered by AI

Would I have the qualifications to join this experiment?

"This investigation seeks to enroll 315 individuals ranging from 18-40 years old that have the CMV virus. To be accepted, participants must meet these criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

2020. "Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04232280.