Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Completed · Phase 2 · Has a placebo group
Conditions studied: Cytomegalovirus Infection
In brief
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
Key facts
- Study ID
- NCT04232280
- Run by
- ModernaTX, Inc.
- People needed
- 315
- Starts
- 2020-01-09
- Expected to finish
- 2023-01-04
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
- Understands and agrees to comply with the trial procedures and provides written informed consent
- According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
- Body mass index (BMI) 18-35 kilograms/meter (kg/m\^2)
- Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding.
- Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination.
You may not qualify if…
- Acutely ill or febrile on the day of the first vaccination
- Prior receipt of any CMV vaccine
- Abnormal screening safety laboratory test results
- Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures
- Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered >14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations.
- Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
- Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
- Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only)
- Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit
- Participated in an interventional clinical trial within 28 days prior to the day of enrollment
- Is an immediate family member or household member of trial personnel
Where it is running
- Benchmark Research — Sacramento, California, United States
- Optimal Research — Peoria, Illinois, United States
- Johnson County Clin-Trials — Lenexa, Kansas, United States
- Alliance for Multispecialty Research — Lexington, Kentucky, United States
- Aventiv Research Inc — Columbus, Ohio, United States
- Tekton Research Inc — Austin, Texas, United States
- Crossroads Clinical Research — Victoria, Texas, United States
- Foothill Family Clinic — Salt Lake City, Utah, United States
- Foothill Family Clinic-South Clinic — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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