The Coalition for Epidemic Preparedness Innovations (CEPI) is helping to fund a trial of KM Biologics’ mpox vaccine in the Democratic Republic of the Congo (DRC), the epicentre of the virus.
The CEPI-funded trial (NCT07093489) will evaluate the LC16m8 mpox vaccine in African populations in the real world, amid a major outbreak of the virus, which remains a continental public health emergency.
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The International Vaccine Institute (IVI) will serve as the study sponsor while the Institut National pour la Recherche Biomédicale (INRB) in the DRC will act as the co-sponsor. CEPI is providing up to $10.4m to support the trial, which is expected to launch later this year.
The trial will assess the effectiveness of the Lc16m8 vaccine by looking at how many participants, including infants and children aged one year and above, become infected with mpox after being vaccinated in selected health zones considered hot spots for mpox cases. This data will help to inform vaccine and mpox management strategies in the DRC and other mpox endemic regions.
LC16m8 is a live-attenuated vaccine that has been approved in Japan for decades against smallpox. It has also been used in the country during previous mpox outbreaks, where it has demonstrated its safety and effectiveness, including in patients with well-controlled HIV. Three million doses of the vaccine are being donated to the DRC by the Japanese Government.
CEPI CEO Dr Richard Hatchett said: “The vaccination campaign in the DRC provides us with a vital opportunity to gather insights into how effective the well-established LC16m8 vaccine is against preventing mpox disease in a high transmission setting, including in children.
“This could help guide how the vaccine can be used to have the most impact in the future. Research will also strengthen local scientists’ experience in rapidly generating real-world data during outbreaks, which could support faster and more efficient responses to future epidemic threats in the region.”
Mpox is a contagious infectious disease caused by the mpox virus, which is a member of the Poxvirus family. There are two different known forms, or clades, of the mpox virus, known as clade I and clade II.
The World Health Organization (WHO) and Africa Centres for Disease Control and Prevention (CDC) declared an ongoing outbreak of mpox was both a continental and global health emergency in August 2024. The WHO’s declaration of a Public Health Emergency of International Concern was the second time in two years that mpox has been classified as such.
This trial initiation comes after the Japanese Government pledged 3.05 million doses of KM Biologics’ medication to the DRC and other outbreak areas. Emergent and Bavarian Nordic have also each pledged donations of their vaccines to African countries to help control the outbreak.
The US funding cuts to global aid have impacted the DRC and other African countries’ efforts to fight the mpox virus, making vaccination efforts all the more important.
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