mRNA-1647 vaccine for Cytomegalovirus (CMV)
Research type
Research Study
Full title
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
IRAS ID
1004010
Contact name
Lori Panther
Contact email
Sponsor organisation
ModernaTX, Inc.
Eudract number
2020-006051-17
Research summary
Cytomegalovirus (CMV) is a common virus that can spread easily through an infected person’s saliva or other body fluids. It is unusual for a CMV infected person to have symptoms, but when symptoms occur they may include fever, muscles aches, tiredness, sore throat, and/or swollen neck glands. If a pregnant woman has a CMV infection, it may be passed to her unborn child, causing the baby to be born with CMV infection - called “congenital CMV infection.” CMV is the most common congenital viral infection. Children with congenital CMV can have or develop lifelong disabilities such as hearing loss, learning problems, or vision abnormalities and can even die. Use of a safe and effective vaccine may potentially prevent CMV infection. There is currently no approved vaccine to prevent CMV infection.
The main goals of this 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 safety of mRNA-1647.
The study will involve a screening period, a study vaccination phase (Day 1 to Month 7) and a follow-up phase (Up to Month 30). Participants will attend study visits for approximately 30 months, will have safety visits about 14 times and assessments including review of side effects, other vaccines, medications, physical exam, vital signs, pregnancy test, illness symptoms, blood, urine and/or saliva samples.
Women who are pregnant at screening or on Day 1 will not be allowed to join the study. Participants who become pregnant during the study will not receive further study doses but will be followed in the study. Pregnancy safety and outcome data may be collected as permitted. An additional consent will be requested to collect data on the health of the baby and additional testing as part of a separate substudy.
This study is sponsored by ModernaTX, Inc. (Moderna). Approximately 6,900 participants will participate in this study worldwide with about 150 participants from 3 hospitals in the UK.REC name
London - South East Research Ethics Committee
REC reference
21/LO/0811
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion