Brazilian malaria vaccine clinical trials

Brazil’s National Health Surveillance Agency (Anvisa) has authorized Phase I human clinical trials for a new vaccine targeting the Plasmodium vivax parasite. Developed by researchers from the Federal University of Minas Gerais (UFMG), the University of São Paulo (USP), the Vaccine Technology Center (CTVacinas), and the pharmaceutical company Cristália, the vaccine—identified as Vivaxin—uses recombinant chimeric protein technology.

Unlike existing malaria vaccines that target the Plasmodium falciparum parasite, this vaccine is designed for the strain predominant in the Americas and Asia. The initial study will involve 48 healthy volunteers aged 18 to 59 to evaluate safety, tolerability, and immune response over a 12-month period. While pre-clinical studies in mice and primates showed 100% protection, the vaccine is not yet available for public use.

If Phase I is successful, subsequent research phases will involve approximately 300 volunteers, primarily located in the Amazon region, where over 95% of Brazil’s malaria cases occur. The Ministry of Health has projected an investment of R$ 12 million to support the clinical trials through Phases I, II, and III.