Moderna’s CMV Vaccine Candidate Misses in Late Stage Trial
Topline results from a phase 3 study evaluating Moderna’s cytomegalovirus (CMV) vaccine candidate, mRNA-1647, were announced.
The study, which enrolled approximately 7500 women aged 16 to 40 years, assessed the safety, efficacy, and immunogenicity of mRNA-1647 in CMV-seronegative female participants.
- The study was randomized, observer-blind, and placebo-controlled.
- Participants received an intramuscular injection of mRNA-1647 or placebo on days 1, 57, and 169.
Findings showed the study did not meet its primary endpoint of preventing CMV infection in seronegative participants, with vaccine efficacy reported to be between 6% to 23%.
Based on these findings, the Company plans on discontinuing the development of mRNA-1647 in congenital CMV.
Author's summary: Moderna's CMV vaccine candidate failed in a late-stage trial.