A groundbreaking clinical trial will soon evaluate the safety and immunogenicity of Bavarian Nordic’s MVA-BN® mpox vaccine in pregnant and breastfeeding women, as well as infants under two years of age. This pioneering effort, set to launch in early 2025 in Boende, Democratic Republic of Congo (DRC), seeks to address critical gaps in vaccine access for populations at heightened risk of severe complications from mpox infections.
Expanding Access to Vulnerable Populations
Pregnant women and infants face elevated risks of severe outcomes from mpox, including complications such as adverse fetal health impacts and severe disease manifestations in young children. Yet, these groups remain ineligible for the current MVA-BN® vaccine, the only WHO prequalified mpox vaccine available to healthy adults and adolescents. By generating essential safety and immunogenicity data, this trial aims to unlock equitable vaccine access for these underserved groups, mitigating their vulnerability during outbreaks.
Trial Details and Objectives
The clinical trial, funded with $8.1 million from the Coalition for Epidemic Preparedness Innovations (CEPI) and Global Health EDCTP3, will recruit 350 pregnant women and 250 infants aged 6-24 months. It will be conducted as a randomized controlled trial with a 12-month follow-up period. Participants will receive the MVA-BN® vaccine to evaluate its safety and immune response generation.
- Pregnant Women: In the first phase, participants will receive two doses of the vaccine before or after delivery. Researchers will collect blood samples and breastmilk to examine whether maternal antibodies are transferred to newborns through the placenta or breastfeeding.
- Infants: The second phase will involve administering full or half doses of the vaccine to children under two years of age, assessing immune response and safety in this age group.
The University of Antwerp (Belgium) will sponsor the trial, with the University of Kinshasa (DRC) leading scientific research efforts. Key partners include Penta (Italy), ACE Research (Kenya), and Bavarian Nordic, which will supply the vaccine.
Addressing a Global Health Crisis
The urgency of the trial is underscored by the ongoing mpox outbreak in the DRC and neighboring nations, the deadliest on record, with over 37,500 suspected cases and 1,040 fatalities reported this year alone. Children represent a significant portion of these fatalities. The outbreak, driven by the Clade Ib strain of the virus, has raised alarms due to its rapid spread and potentially altered transmission dynamics.
CEPI’s Executive Director of Preparedness and Response, Dr. Nicole Lurie, emphasized the importance of protecting vulnerable populations, stating, “This study is a vital step in ensuring that pregnant women and infants, who are among the most at-risk, can benefit from effective vaccines.”
A Collaborative Approach
This initiative reflects a collaborative global effort. The trial is part of CEPI’s broader strategy to accelerate vaccine access in Africa, which includes two additional studies of the MVA-BN® vaccine in the region. Global Health EDCTP3’s Executive Director, Dr. Michael Makanga, lauded the trial’s focus on addressing unmet health needs, noting its potential to inform global vaccination strategies while enhancing local research capacity.
Future Implications
The findings from this trial could shape vaccine policy for priority populations worldwide. The research will be openly published, ensuring that the data benefits the global public health community. This work aligns with CEPI’s mission to compress vaccine development timelines, a critical goal in combating epidemic and pandemic threats.
Strengthening Global Health
This study not only aims to address a pressing public health need but also to strengthen local healthcare infrastructure in Africa. The trial aligns with efforts to expand access through existing immunization programs, such as the Expanded Programme on Immunisation (EPI) and antenatal care consultations.
As Professor Hypolite Muhindo Mavoko of the University of Kinshasa remarked, “This trial is an essential step in addressing critical health gaps for vulnerable populations while also enhancing our capacity to respond to future crises.”
By fostering equitable vaccine access, the trial represents a significant advance in global health preparedness, offering hope for better protection against mpox for those who need it most.
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