Africa CDC and PANTHER Launch Mpox Study in Africa to Evaluate Brincidofovir
核心洞察
The Africa CDC (搜索) and PANTHER (搜索) have launched the Mpox (搜索) Study in Africa (MOSA) to address the urgent need for effective Mpox treatments.
MOSA will evaluate the safety and efficacy of brincidofovir, an antiviral drug, in a pan-African randomized platform adaptive trial.
The trial will begin in the Democratic Republic of Congo and neighboring countries, focusing on vulnerable populations including children and individuals living with HIV.
The Africa Centres for Disease Control and Prevention (Africa CDC (搜索)), in partnership with the Pandemic Preparedness Platform for Health and Emerging Infections Response (PANTHER (搜索)), has announced the launch of the Mpox (搜索) Study in Africa (MOSA). This clinical trial aims to advance research for Mpox treatment across the continent, where the disease remains a significant health threat, particularly among vulnerable populations.
Mpox (搜索) was declared a Public Health Emergency of Continental Security on August 13, 2024. Despite the pressing need, there is currently no approved therapeutic to treat Mpox and alleviate the suffering of those already infected and at risk of severe complications. MOSA represents Africa’s leadership in addressing this healthcare gap through a pan-African randomized platform adaptive trial.
Brincidofovir Evaluation
The study will initially evaluate the safety and efficacy of brincidofovir, an antiviral drug developed by Emergent BioSolutions. Brincidofovir is currently approved for smallpox in the U.S. and has emergency Investigational New Drug (IND) access for Mpox (搜索). However, it has not yet undergone double-blind placebo-controlled studies for Mpox. Emergent BioSolutions is providing the study drugs and placebo free of charge.
Trial Design and Implementation
The MOSA trial will commence in the Democratic Republic of Congo (DRC) and neighboring countries in the fourth quarter of 2024. The study will recruit both children and adults, focusing on those most at risk of severe outcomes, especially in remote areas. The trial protocol was reviewed through the African Vaccine Regulatory Forum (AVAREF) collaborative process in 2023, ensuring adherence to the highest ethical and scientific standards. The study design includes pre-planned interim analyses, allowing for rapid decision-making based on early signs of futility or success.
Leadership Perspectives
"Africa is not just responding to the Mpox (搜索) outbreak, we are leading the charge in finding solutions by spearheading research and development for Mpox therapeutics," said Dr. Jean Kaseya, Director General of Africa CDC (搜索). "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."
Prof. Samba Ousmane Sow, Director General of the Centre for Vaccine Development in Mali (CVD-Mali) and President of the Board of PANTHER (搜索), added, "The launch of MOSA marks a significant stride in the fight against Mpox (搜索) and underscores Africa’s leadership in global health research and innovation. Our joint efforts with Africa CDC (搜索) will not only address an urgent health crisis but will also set a new precedent for African-led research initiatives."