mRNA-1647 CMVictory Phase 3 Topline
First Phase 3 efficacy readout for any cytomegalovirus (CMV) vaccine — no CMV vaccine has ever been approved. Watch: vaccine efficacy against primary CMV infection in seronegative women aged 16–40, primary endpoint pre-specified at p<0.025.
What’s at stake
mRNA-1647 is Moderna's investigational cytomegalovirus (CMV) vaccine designed to protect against the most common cause of congenital viral infection in the United States. The vaccine encodes six CMV surface proteins — including the gH/gL pentameric complex — to elicit a broader immune response than prior single-antigen approaches that have failed in clinical trials. CMV infects roughly 1 in 200 infants born each year, causing permanent hearing loss and developmental disability; no CMV vaccine has ever been approved, making this the first Phase 3 efficacy trial for any CMV candidate.
No primer in glossary yet.
Competitive landscape
Prior MRNA reactions to Readout events
| Date | Headline | Outcome | 1W | 1M | 6M |
|---|---|---|---|---|---|
| Apr 2026 | mRNA-1083 P304 Flu+COVID Phase 3 Topline | positive | +32.0% | +43.9% | +28.7% |
Disclosure trail
- May 8, 2026·-11247m agopinned · highest confidenceHIGH conf10-QMONTHtop claimDEC2026
“For our CMV vaccine candidate mRNA-1647, we anticipate primary efficacy data from the Phase 3 CMVictory trial in December 2026.”
contextMD&A — Recent Developments section, Form 10-Q for Q1 2026.
conf 89%via llm