A landmark clinical trial will commence in early 2025 in the Democratic Republic of Congo (DRC) to evaluate the safety and effectiveness of Bavarian Nordic’s MVA-BN® mpox vaccine in pregnant and breastfeeding women, as well as infants under two years old. The trial aims to address a critical gap in vaccine accessibility for these vulnerable populations, who face heightened risks from the ongoing mpox outbreak in the DRC.

The study, to be conducted in Boende, DRC, will involve 350 pregnant women and 250 children aged 24 months or younger. It will assess the vaccine’s safety and immunogenicity, potentially paving the way for broader use of the MVA-BN vaccine, which is currently the only WHO-prequalified mpox vaccine available for healthy adults and adolescents.

"Pregnant women and infants are particularly vulnerable to mpox, but their access to the MVA-BN vaccine remains limited due to insufficient data on its safety and effectiveness for these groups," said Dr Nicole Lurie, Executive Director of Preparedness and Response at the Coalition for Epidemic Preparedness Innovations (CEPI), which is funding the trial.

The trial’s launch comes amid a worsening mpox outbreak in the DRC, with over 37,500 suspected cases and 1,040 deaths reported this year, many involving children. Mpox has been declared a global public health emergency, underscoring the urgency of expanding vaccine accessibility to underserved populations.

The USD 8.1 million trial is a collaborative effort supported by CEPI and Global Health EDCTP3, with funding contributions of USD 6.4 million and USD 1.7 million, respectively. Key partners include the University of Antwerp (Belgium), the University of Kinshasa (DRC), Penta (Italy), and ACE Research (Kenya). Bavarian Nordic will provide the vaccine doses for the study.

Dr Michael Makanga, Executive Director of Global Health EDCTP3, highlighted the importance of addressing unmet needs: "This trial exemplifies our commitment to improving vaccine accessibility for vulnerable groups. Partnering with CEPI allows us to respond swiftly to the mpox crisis."

The trial will follow a randomised controlled design, with participants monitored over 12 months. In the first phase, pregnant women will receive two doses of the vaccine either before or after childbirth, with researchers examining maternal antibody transfer to infants through blood and breast milk samples. The second phase will involve administering the vaccine to infants aged 6–24 months and testing both full and half doses.

The study's findings will be shared through open-access publications to guide global public health strategies and further research. By addressing the pressing need for vaccine data in these high-risk populations, the trial could play a pivotal role in reshaping the global response to mpox and protecting the most vulnerable communities.

 

Article by Jed Mwangi

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https://cepi.net/new-study-assess-mpox-vaccine-pregnant-women-and-infants