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Cancer Vaccine
mRNA-1647 Vaccine for Cytomegalovirus Infection
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
Having a negative (CMV-seronegative) or a positive (CMV-seropositive) result using a blood IgG assay performed at the central laboratory or a previously documented seropositive result
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 29, day 57, day 87, day 237, day 365, day 466, and day 542
Awards & highlights
Study Summary
This trial assesses a potential vaccine to prevent a virus in liver transplant recipients, plus its safety, effectiveness, and immune response.
Who is the study for?
This trial is for liver transplant candidates who are either CMV-seropositive or seronegative, expected to receive a transplant within 2-12 months. Participants must not be of childbearing potential or agree to use contraception and cannot have had previous transplants, certain hypersensitivities, HIV infection, other organ transplants planned, or conditions that may risk participation.Check my eligibility
What is being tested?
The study tests mRNA-1647 vaccine's effectiveness in preventing cytomegalovirus (CMV) infections after liver transplantation. It compares the outcomes between those given the vaccine and those receiving a placebo. The focus is on virologic outcomes post-transplant and the safety and immune response to the vaccine.See study design
What are the potential side effects?
Potential side effects include allergic reactions to components of mRNA vaccines like mRNA-1647 or its excipients. Other common side effects from similar vaccines can include pain at injection site, fatigue, headache, muscle pain, chills, fever, nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood test for CMV is either positive or negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 29, day 57, day 87, day 237, day 365, day 466, and day 542
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 29, day 57, day 87, day 237, day 365, day 466, and day 542
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 Events Leading to Discontinuation
Number of Participants With Adverse Events of Special Interest
Number of Participants With Medically Attended Adverse Events
+4 moreSecondary outcome measures
Number of Participants With Investigator-reported CMV Disease
Number of Seropositive Participants With CMV Disease, Defined as Adjudicated CMV Disease
Post-transplant: All-cause Mortality
+22 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: mRNA-1647Experimental Treatment1 Intervention
CMV-seronegative and CMV-seropositive participants will receive 3 intramuscular (IM) injections of mRNA-1647 vaccine on Days 1, 29, and 57.
Group II: PlaceboExperimental Treatment1 Intervention
CMV-seronegative and CMV-seropositive participants will receive 3 IM injections of mRNA-1647 vaccine-matching placebo on Days 1, 29, and 57.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
mRNA-1647
2021
Completed Phase 2
~510
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,378,125 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you outline the potential health risks associated with mRNA-1647?
"With clinical evidence that mRNA-1647 is safe, our team at Power rated the medication a 2 on its scale. This rating reflects this being a Phase 2 trial with limited data regarding efficacy."
Answered by AI
Are individuals currently able to enroll in this research endeavor?
"Currently, per clinicaltrials.gov, this specific trial is not recruiting individuals due to its last update on November 10th 2023. However, 815 other trials continue their search for participants."
Answered by AI
What is the extent of deployment for this clinical trial?
"At this time, 26 sites across the country are accepting patients for participation in the trial. Examples of locations include Jacksonville, Birmingham and Los Angeles - amongst other destinations. To alleviate any potential travel pressure, please select a site within proximity to your home."
Answered by AI
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