The Democratic Republic of the Congo (DRC) is preparing to launch Africa’s first large-scale study of the LC16m8 mpox vaccine, a landmark trial that global health leaders say could reshape outbreak preparedness and future immunisation campaigns across the continent.

Backed by up to US$10.4 million from the Coalition for Epidemic Preparedness Innovations (CEPI), the study will assess the vaccine’s safety and effectiveness during one of Africa’s most severe mpox outbreaks in recent history.

“This is a vital opportunity to understand how the LC16m8 vaccine performs in African populations, including children, in a high-transmission environment,” said Dr. Richard Hatchett, CEPI’s Chief Executive Officer. “The data will inform how to deploy the vaccine for maximum impact and strengthen Africa’s ability to respond faster to future epidemic threats.”

Pending regulatory and ethics approvals, the trial will begin later this year under the leadership of the Institut National pour la Recherche Biomédicale (INRB) in Kinshasa. The International Vaccine Institute (IVI) will serve as sponsor, with the Japan Institute for Health Security as co-investigator. Fieldwork will be concentrated in Equateur Province, one of the hardest-hit regions, where infection rates and safety outcomes will be closely monitored.

“The DRC will be the first African country to generate essential field data on the LC16m8 vaccine,” said Health Minister Samuel Roger Kamba. “This collaboration is a turning point in our ability to protect the most vulnerable and to generate evidence for Africa, in Africa.”

To support the campaign, Japan is donating three million doses of LC16m8, a vaccine manufactured by KM Biologics and used safely for decades in Japan against smallpox and during past mpox outbreaks.

Mpox remains a global health emergency, with the World Health Organisation (WHO) and Africa CDC declaring the ongoing outbreak a Public Health Emergency of International Concern (PHEIC) in August 2024 — the second such designation in two years.

“Children and other vulnerable populations need protection backed by solid evidence,” said Dr. Jean Kaseya, Director General of Africa CDC. “This study will build that evidence and strengthen health security for the continent.”

Beyond immediate outbreak response, the trial is expected to boost Africa’s scientific capacity by training local researchers to collect and analyse real-time outbreak data. Experts say the findings could not only inform mpox strategies but also guide preparedness for future infectious disease threats.

 

Article by Jed Mwangi

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https://cepi.net/new-mpox-vaccine-study-launch-outbreak-affected-drc