Moderna CMV Victory
ModernaTX, Inc. / A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine
Open to recruitment: Open to recruitment
Aim of the study: The purpose of the trial is to (1) evaluate the safety and effectiveness of an investigational vaccine against cytomegalovirus (CMV) infection in women who have not had prior CMV infection and (2) evaluate its safety in women who test positive to prior exposure to CMV.
- A woman between 16-40 years of age
- In good health
- In close contact with at least one child 5 years of age or younger for at least 8 hours a week, if age 20 or older
- Not pregnant or planning on becoming pregnant within the next 9 months
What participating in the study involves:
All eligible individuals who are screened for this clinical trial will receive a physical exam, a pregnancy test, and some blood tests for CMV immunoglobulin G (IgG)/immunoglobulin M (IgM). The screening blood tests will look to see whether they have been previously exposed to CMV. Based on the results of the blood tests, participants who meet the eligibility criteria for the trial will be randomized into 1 of 2 cohorts, CMV-Seropositive or CMV-Seronegative. Randomization in each cohort is performed 1:1, investigational vaccine to placebo, so a member of either cohort has a 50% chance of receiving the trial vaccine or a 50% chance of receiving a placebo. Aside from receiving 3 injections in the upper arm over a 6-month time frame, the trial includes 15 total visits (1 screening visit, 5 in-person visits during the first 7 months and then in-person visits approximately every 3 months) and 21 safety phone calls or electronic (eDiary) safety check prompts over a 2.5-year time frame.