- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05105048
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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North Hollywood, California, United States, 91606
- Velocity Clinical Research
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San Diego, California, United States, 92123
- California Research Foundation
-
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Hawaii
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Honolulu, Hawaii, United States, 96814
- East-West Medical Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant is a Japanese Adult 18-40 years of age at the time of consent who, in the opinion of the investigator, is in good health based on review of medical history and screening physical examination. Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan, and who have not lived outside of Japan for more than 10 years in total.
- For the CMV-seronegative groups: Participant is serum CMV IgG negative/ IgM negative.
- For the CMV-seropositive groups: Participant is either serum CMV IgG positive/IgM negative or IgG positive/IgM positive.
- Participant has a body mass index (BMI) from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2, inclusive.
Exclusion Criteria:
- History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- Participant has elevated liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP), or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at screening.
- Participant has laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1 at screening.
Received or plans to receive any non-study vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
i. Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
ii. COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
iii. Influenza vaccines may be administered >14 days prior to or after any study injection.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before the day of first injection (Day 1) (for corticosteroids, >5 mg/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
- Participant has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) within 2 weeks before the first injection or plans to do so during the course of the study.
- Participant received any investigational CMV vaccine.
- History of myocarditis, pericarditis, or myopericarditis.
- Reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HbSAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.
Other inclusion and exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mRNA-1647
CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule.
|
Lyophilized product that is reconstituted with saline
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Placebo Comparator: Placebo
CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule.
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0.9% sodium chloride (normal saline) injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 176 (7 days after each injection)
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Up to Day 176 (7 days after each injection)
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Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 197 (28 days after each injection)
|
Up to Day 197 (28 days after each injection)
|
Number of Participants With Medically-Attended AEs (MAAEs)
Time Frame: Day 1 through 6 months after the last injection (up to Day 347)
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Day 1 through 6 months after the last injection (up to Day 347)
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Number of Participants With Serious AEs (SAEs)
Time Frame: Day 1 through End of Study (EOS) (up to Day 347)
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Day 1 through End of Study (EOS) (up to Day 347)
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Number of Participants With AEs of Special Interest (AESIs)
Time Frame: Day 1 through EOS (up to Day 347)
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Day 1 through EOS (up to Day 347)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame: Days 1, 29, 85, 169, 197, and 347
|
Days 1, 29, 85, 169, 197, and 347
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Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame: Days 29, 85, 169, 197, and 347
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Days 29, 85, 169, 197, and 347
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Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame: Days 29, 85, 169, 197, and 347
|
Days 29, 85, 169, 197, and 347
|
GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time Frame: Days 1, 29, 85, 169, 197, and 347
|
Days 1, 29, 85, 169, 197, and 347
|
GMFR of Anti-gB and Anti-Pentamer Specific IgG
Time Frame: Days 29, 85, 169, 197, and 347
|
Days 29, 85, 169, 197, and 347
|
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG
Time Frame: Days 29, 85, 169, 197, and 347
|
Days 29, 85, 169, 197, and 347
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mRNA-1647-P103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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