Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 40 Years|
- - 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.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of low, medium, and high dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.
Experimental: mRNA-1647 Low Dose
Participants will receive mRNA-1647 vaccine at the Low Dose by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
Experimental: mRNA-1647 Medium Dose
Participants will receive mRNA-1647 vaccine at the Medium Dose by IM injection on Day 1, Day 56, and Day 168.
Experimental: mRNA-1647 High Dose
Participants will receive mRNA-1647 vaccine at the High Dose by IM injection on Day 1, Day 56, and Day 168.
Placebo Comparator: Placebo
Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.
Biological: - mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
Other: - Placebo
0.9% sodium chloride (normal saline) injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.