The single-dose dengue vaccine developed by Brazil’s Butantan Institute is 80.5% effective against hospitalization for the mosquito-borne disease for at least five years, per a phase 3 clinical trial published in Nature Medicine.
Led by Butantan Institute researchers, the double-blind, placebo-controlled trial estimated the safety and effectiveness of the live, attenuated, tetravalent (four-strain) Butantan-DV vaccine in participants aged two to 59 years. Participants were randomly assigned to receive the vaccine (10,259 people) or placebo (5,976) at 16 Brazilian research centers from 2016 to 2019.
The main goal was to evaluate the vaccine effectiveness (VE) against symptomatic dengue 28 days post-vaccination due to any dengue virus serotype (variant), regardless of serostatus (antibody presence or absence). Secondary endpoints were VE by serotype, by serostatus, and protection against severe dengue or dengue with warning signs (combined).
The Brazilian Health Regulatory Agency approved Butantan-DV in November 2025 for use in people aged 12 to 59 years.
“The spread of dengue has greatly increased worldwide over the past two decades,” the authors wrote. “Natural infection by one dengue virus (DENV) serotype allows homotypic protection [against the same strain] but subsequent heterotypic infection by another of the four DENV serotypes (DENV-1 through DENV-4) can result in severe disease.”
Individual protection, reduced viral circulation
Over five years, no vaccinated participants were hospitalized. VE against symptomatic dengue was 65.0%. VE was 77.1% in previously infected participants, 58.9% in dengue-naive participants, 73.0% against DENV-1, and 55.7% against DENV-2. Cases of DENV-3 and DENV-4 weren’t observed.