As critical discussions at the World Health Summit in Berlin conclude, the Africa CDC, in partnership with PANTHER, proudly announces its first direct contribution to the Mpox Study in Africa (MOSA). This pivotal clinical trial aims to advance research for Mpox treatment across the continent.
Declared a Public Health Emergency of Continental Security on 13 August 2024, Mpox persists as a significant health threat across Africa, particularly in vulnerable populations such as women, children, patients with mucosal lesions, and individuals living with HIV. Despite the pressing need, there is currently no therapeutic approved to treat Mpox and alleviate the suffering of those already infected and at risk of severe complications.
MOSA, a pan-African randomized platform adaptive trial, demonstrates Africa's leadership in addressing this urgent healthcare gap. The study will start by evaluating the safety and efficacy of brincidofovir, an antiviral from global life sciences company, Emergent BioSolutions. Brincidofovir is currently approved for smallpox in the U.S. and has emergency Investigational New Drug (IND) access for Mpox; however, brincidofovir has not yet undergone double-blind placebo-controlled studies for Mpox. The trial will begin in the Democratic Republic of Congo (DRC) and neighboring countries, starting in fourth quarter of 2024. Africa CDC and PANTHER express their gratitude to Emergent for generously providing the study drugs and placebo free of charge, a critical contribution to advancing this research.
"Africa is not just responding to the Mpox outbreak, we are leading the charge in finding solutions by spearheading research and development for Mpox therapeutics," said Director General of Africa CDC, Dr. Jean Kaseya. "The Mpox Study in Africa is a groundbreaking step towards developing an effective treatment that will save lives. This is about more than just research--it's about African ownership and leadership in tackling our continent's health challenges through critical research."
Sponsored by PANTHER, a key partner of Africa CDC for health research, the MOSA trial builds upon initial funding provided by the European Union's Horizon Europe program. The study protocol was reviewed through the African Vaccine Regulatory Forum (AVAREF) collaborative process in 2023, ensuring that it meets the highest ethical and scientific standards. The innovative study design includes pre-planned interim analyses, allowing for rapid decision-making should early signs of either futility or success be observed.
"The launch of MOSA marks a significant stride in the fight against Mpox and underscores Africa's leadership in global health research and innovation," said Prof. Samba Ousmane Sow, Director General of the Centre for Vaccine Development in Mali (CVD-Mali) and President of the Board of PANTHER. "Our joint efforts with Africa CDC will not only address an urgent health crisis but will also set a new precedent for African-led research initiatives."
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As Africa continues to witness rising Mpox cases, particularly in the DRC, the MOSA trial seeks to provide critical data on potential treatment options. The study will recruit both children and adults. It will focus on those most at risk of severe outcomes, especially in remote areas.
