Brazil’s health regulator Anvisa has approved the first human trial of Vivaxin, a vaccine candidate for malaria caused by Plasmodium vivax. The authorization allows clinical research, not public use. In Phase 1, researchers will assess safety, reactions to the injection and immune response; the study won’t establish whether the vaccine protects people.
The approval appeared in Brazil’s federal official gazette on Wednesday, October 7, 2026, after Anvisa issued Resolution-RE No. 3,956 on October 6. CTVacinas at the Federal University of Minas Gerais (UFMG), the University of São Paulo (USP) and laboratory Cristália developed the vaccine. Researchers will conduct the trial at the clinical research centre of the Hospital das Clínicas of UFMG in Belo Horizonte, capital of Minas Gerais state.
What the trial will test
Researchers plan to enrol 48 healthy volunteers aged 18 to 59 who have never had malaria. Participants will receive three doses, 28 days apart, and researchers will follow them for 360 days. The developers describe the trial as double-blind, randomised and placebo-controlled.
Phase 1 results should guide later stages of clinical development. The source gives no date for the start of volunteer recruitment, nor a timetable for results or a later trial to test protection. Later trials would need to show that the vaccine protects people before authorities could approve it for public use.
Vivaxin combines three variants of a parasite surface protein called PvCSP in one molecule. The candidate aims to stop the parasite before it reaches the liver. Brazilian research reports found that the formulation fully prevented infection in some mice, but those findings don't predict how people will respond. Vaccines that work in animals can fail in humans.
A disease concentrated in the Amazon
Brazil recorded 118,037 malaria cases in 2025, with more than 99% in the Amazon region, according to CTVacinas. Ricardo Gazzinelli, who coordinates the centre, said the disease keeps people from working and has a large socioeconomic effect.
Plasmodium vivax caused about 63% of estimated malaria cases in the Americas in 2024, according to the World Health Organization’s World Malaria Report. The WHO-recommended vaccines RTS,S and R21/Matrix-M target Plasmodium falciparum, the dominant malaria parasite in sub-Saharan Africa. The developers say no vaccine against vivax malaria is available to the public anywhere in the world.
Public funding and next steps
Brazil’s science ministry, its national science fund, the Finep innovation agency and the Ministry of Health fund the Vivaxin project. Those public funders work with the named universities and laboratory. The article does not describe any change in regulatory authority beyond Anvisa’s approval of the clinical development dossier and research process.
Years remain before any possible approval. People heading to the Amazon should continue to follow medical advice on malaria prevention. The trial will provide information about safety and immune response, but whether Vivaxin can prevent infection in people remains to be tested. Participants will receive three doses, spaced 28 days apart.