Brazil's health regulator has authorised the first human trial of Vivaxin, a vaccine candidate against Plasmodium vivax malaria developed at the Universidade de São Paulo's School of Pharmaceutical Sciences together with the Vaccine Technology Center at the Federal University of Minas Gerais. The approval, published in the official gazette in October 2026, clears a Phase 1 study of 48 healthy adults aged 18 to 59 who have never had malaria, with recruitment scheduled to begin in January 2027.
Participants will receive three doses, 28 days apart, of either the vaccine or a placebo, and will be followed for a year to assess safety and antibody response. The candidate is built around a chimeric protein that combines three variants of the parasite's circumsporozoite protein, paired with an adjuvant developed in Belo Horizonte. Preclinical studies in mice and primates reported strong immunogenicity and complete protection, and the Brazilian pharmaceutical company Cristália is producing the trial batches.
The stakes are considerable. No vaccine against P. vivax is currently available anywhere in the world, even though the World Health Organization's 2025 report recorded 9.9 million vivax cases globally and the parasite accounts for 63 per cent of malaria in the Americas. Brazil logged 118,037 locally acquired cases in 2025, over 95 per cent of them in the Amazon, and has set itself the goal of eliminating local transmission by 2035. If Phase 1 confirms safety, later phases would enrol around 300 people, mainly in the Amazon region.