Anvisa authorizes human trials for first Brazilian malaria vivax vaccine

Brazil's National Health Surveillance Agency (Anvisa) has authorized Phase 1 human clinical trials for Vivaxin, the world's first vaccine developed to prevent malaria caused by the Plasmodium vivax parasite. This specific type of malaria is the most common in Brazil and the Americas, and currently, no vaccine exists globally for it.

Developed through a partnership between the University of São Paulo (USP), the Vaccine Technology Center (CTVacinas) at the Federal University of Minas Gerais (UFMG), and the pharmaceutical company Cristália, the vaccine uses recombinant chimeric protein technology. The goal is to induce antibodies that prevent the parasite from reaching the liver and multiplying in the bloodstream.

The initial study will evaluate safety, tolerability, and immune response in 48 healthy volunteers aged 18 to 59. Participants will receive three doses at 28-day intervals and undergo a 12-month follow-up. Pre-clinical studies in mice and primates showed 100% protection. If Phase 1 is successful, subsequent phases will involve approximately 300 volunteers, primarily in the Amazon region, where over 95% of Brazil's malaria cases occur.