New study to assess mpox vaccine in pregnant women and infants
November 6, 2024
A groundbreaking $8.1 million trial of Bavarian Nordic's MVA-BN mpox vaccine will begin in DRC in early 2025, targeting pregnant women and infants under two. The study, funded by CEPI ($6.4M) and Global Health EDCTP3 ($1.7M), will evaluate the vaccine's safety in these high-risk populations currently ineligible for vaccination. About 350 pregnant women and 250 young children will participate in Boende, DRC, where the current outbreak has caused over 37,500 suspected cases and 1,040 deaths this year. The trial aims to expand vaccine access to vulnerable groups through a two-stage approach testing maternal antibody transfer and infant dosing options.
A major scientific trial of Bavarian Nordic's MVA-BN mpox vaccine is set to launch in the Democratic Republic of Congo, focusing on previously excluded high-risk populations.
Key Trial Details:
1. Scope and Participants:
- 350 pregnant women
- 250 children under two years
- Located in Boende, DRC
- Starting early 2025
- 12-month follow-up period
2. Funding and Partners:
- Total budget: $8.1 million
- CEPI contribution: $6.4 million
- Global Health EDCTP3: $1.7 million
- University of Antwerp as Trial Sponsor
- University of Kinshasa as Scientific Leader
- Bavarian Nordic providing vaccines
3. Study Design:
- Two-stage randomized controlled trial
- First stage: Maternal vaccination pre/post-birth
- Second stage: Infant vaccination (6-24 months)
- Testing full and half doses
- Monitoring antibody transfer through breast milk
4. Context and Significance:
- Current DRC outbreak: 37,500+ suspected cases
- 1,040 fatalities reported
- Only WHO-prequalified vaccine
- First data for pregnant women and infants
- Open-access publication of results
5. Expected Impact:
- Expand vaccine access to vulnerable groups
- Inform current outbreak response
- Guide future research
- Strengthen local research capacity
- Support routine vaccination programs
This trial represents a crucial step in protecting vulnerable populations from mpox while building evidence for global vaccine deployment strategies.