CMVibe - A Phase 1/2a study for a Cytomegalovirus (CMV) Vaccine in Adult and Paediatric Participants
Research type
Research Study
Full title
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
IRAS ID
1005458
Contact name
Lori Panther
Contact email
Sponsor organisation
ModernaTX, Inc.
Eudract number
2022-001545-20
Clinicaltrials.gov Identifier
Research summary
Moderna is conducting a clinical trial, called the CMVibe Trial, on an investigational vaccine that may protect against cytomegalovirus (CMV). CMV is a common and often overlooked virus with lifelong impact. For most people, the symptoms of CMV, if there are any, can resemble the common cold with fatigue, headache, and sore throat. Once someone is infected with CMV, it stays latent or “sleeps” in the body for life. At certain times in a person’s life, such as pregnancy, CMV can reactivate. An active CMV infection during pregnancy puts the unborn baby at risk of birth defects. These include hearing loss, vision loss, or cerebral palsy, which can lead to long-term disability or, in severe cases, death. There is currently no approved vaccine to prevent CMV infection. The main goals of this Phase 1/2a study are to understand if mRNA-1647 study vaccine can prevent CMV infection in those who have not had CMV infection before, and to assess the safety of mRNA-1647. This trial is enrolling volunteers 9 to 15 years of age and females 16 to 25 years of age. The study will be conducted in 2 parts. Female participants 16 to 25 years of age are included as comparators in Part 1. Participation in this trial lasts up to 18 months and includes up to 12 in-person visits to the trial site and 11 phone calls. Participants will receive 3 injections of mRNA-1647 over the first 6 months of the trial. Participants will have assessments including physical examinations, vital signs, a baseline 12-lead ECG, pregnancy tests, and give blood, urine and possibly saliva samples. They will also be asked to complete an eDiary on a smartphone or tablet about 30 minutes after they receive the first injection and for 6 days after each injection. Approximately 770 participants will be enrolled in 2 parts of the study; 310 participants in Part 1 (open label Dose Ranging) and 460 participants in Part 2 (randomized Safety Expansion).
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0433
Date of REC Opinion
28 Feb 2023
REC opinion
Further Information Favourable Opinion