PregInPoxVac

Project summary

The PregInPoxVac study evaluates the safety and immunogenicity of the MVA-BN mpox vaccine in pregnant women and infants, in the Democratic Republic of the Congo (DRC), compared to adults for whom the vaccine has been approved. The trial also entails the development of an ancillary care policy and the conduct of qualitative research on vaccine and trial acceptability by the potential participants and the community.

Visit the project website
Visit the project summary on the EDCTP3 website

Consortium partners

  • University of Antwerp (coordinator)
  • University of Kinshasa
  • Fondazione Penta ETS
  • Africa Clinical Research

Funders

  • The Third European and Developing Countries Clinical Trials Partnership Programme (EDCTP3)
  • the Coalition for Epidemic Preparedness Innovations (CEPI)
  • Bavarian Nordic provides the mpox vaccines

Project duration

August 2024 – September 2028

Geographical scope

This trial is set up in Boende, the capital city of the Tshuapa province and an mpox endemic area in the DRC.

Research area

  • Vaccination
  • Social and behavioral research

About PregInPoxVac

The vaccine trial

The main objectives are to evaluate the safety and immune response of the MVA-BN mpox vaccine in:

  • healthy pregnant women and women who have recently given birth (both aged 16 to 35), and their neonates. The study assesses the safety and immune responses in vaccinated mothers and assesses the safety and maternally-derived antibody transfer to neonates. This component of the vaccine trial is open-label and randomised.
  • infants and children aged 4 to 24 months. The study assesses a full-dose regimen versus a half-dose regimen, and compares both to the full-dose regimen in adults. This component of the vaccine trial is double-blinded and randomised.

 

Community engagement and ancillary care

Historically, pregnant women and children have often been excluded from vaccine research, which can contribute to questions or concerns about vaccination and participation in clinical trials. Clear, transparent communication and sustained community engagement throughout the trial will be essential to support understanding, trust, and informed decision making regarding both the study and the vaccine.

To ensure community engagement and contextual relevance, the study incorporates activities designed to listen and incorporate community perspectives. Pre-trial workshops with key stakeholders will explain the trial, gather feedback on trial procedures, and identify context-specific barriers and facilitators. Insights will shape study materials, policies and recruitment strategies, while key messages will be shared through local medical and health authorities. After the trial, focus group discussions will explore strategies for effective dissemination of trial results and vaccine rollout.

Furthermore, an ancillary care policy is in place to cover all study and non-study-related adverse events during trial participation.