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Virus Therapy
mRNA-1647 Vaccine for Cytomegalovirus Infection
Phase 2
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 9
Awards & highlights
Study Summary
This trial will study if a new drug (mRNA-1647) can help prevent a virus infection after a stem cell transplant.
Who is the study for?
This trial is for adults who've had a bone marrow transplant, are at high risk for CMV infection, and have working major organs. They must not be pregnant or breastfeeding, agree to use contraception, and can't have HIV or recent treatments that weaken the immune system.Check my eligibility
What is being tested?
The study tests mRNA-1647 vaccine's effectiveness in preventing significant CMV infections after stopping standard anti-CMV drugs post-transplant. Participants will either receive the vaccine or a placebo to compare results.See study design
What are the potential side effects?
Potential side effects of mRNA-1647 may include typical reactions seen with other vaccines such as pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9
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 Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Severe AEs
+3 moreSecondary outcome measures
Duration of CMV Treatment
Duration of CMV Viremia
Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
+7 moreTrial 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 42, Day 67, and Day 92, and a booster dose on Day 180.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1647
2021
Completed Phase 2
~510
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,093 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at low risk for CMV after a stem cell transplant from a related or unrelated donor.I am at high risk for CMV due to my stem cell transplant type or donor match.I had a bone marrow transplant less than a year ago.I have received a stem cell transplant from a donor.I am not able to have children or I can and have a negative pregnancy test.I haven't had treatments like Campath or ATG in the last year.I have had a stem cell transplant with T cell removal.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: mRNA-1647
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings in this research endeavor for participants?
"Data hosted on clinicaltrials.gov informs us that this research trial is no longer seeking participants, having been initially posted on January 30th 2023 and last updated on April 1st 2023. Despite this, there are still 769 ongoing medical trials actively recruiting patients at present."
Answered by AI
What risks have been identified for those receiving mRNA-1647 treatments?
"Data indicating the safety of mRNA-1647 is present, thus giving a score of 2. There isn't any evidence yet that this medication has efficacy in patients at this time."
Answered by AI
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