New study to assess mpox vaccine in pregnant women and infants

Trial to evaluate safety and efficacy of MVA-BN vaccine

A new scientific trial evaluating Bavarian Nordic’s mpox vaccine in pregnant and breastfeeding women and infants is set to launch in the Democratic Republic of Congo (DRC).

This research could expand access to Bavarian Nordic’s MVA-BN mpox vaccine, currently the only WHO prequalified vaccine for healthy adults and adolescents, to include these vulnerable populations.

“Pregnant women and infants are particularly vulnerable to mpox, but their access to the MVA-BN vaccine will be limited until there is more data about its safety and immunogenicity in these populations,” said Dr Nicole Lurie, Executive Director of Preparedness and Response at CEPI.

The study will involve around 350 pregnant women and 250 children under two years old. It will assess the safety and immunogenicity of the MVA-BN® vaccine in these populations for the first time.

The trial will commence in Boende, DRC, in early 2025.

“I am thrilled that we are working with Global Health EDCTP3 and an international group of partners to make a vital contribution to protecting those most at risk of this devastating disease,” added Dr Lurie.

Jointly funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and Global Health EDCTP3, the USD 8.1 million trial aims to provide essential insights that could expand vaccine options for vulnerable groups.

Dr Michael Makanga, Executive Director of Global Health EDCTP3, said, “Global Health EDCTP3 has been at the forefront of the Mpox outbreak response. Addressing major unmet needs of underserved groups is at the core of the work we fund.”

The research will run as a randomised controlled trial with a twelve-month follow-up.

Blood samples and breastmilk will be collected to assess maternal antibody transfer to infants.

Professor Jean-Pierre Van Geertruyden of the University of Antwerp noted, “Infants and pregnant women are easy to reach via well-established routine programmes, such as the Expanded Programme on Immunisation (EPI) and antenatal consultations.”