Live, Attenuated, Tetravalent Butantan–Dengue Vaccine in Children and Adults

作者：Esper Georges Kallas, Monica A T Cintra, J. A. A. Moreira, Elizabeth González Patiño, Patricia Emília Braga, Juliana C V Tenório, Vanessa Infante, Ricardo Palácios, Marcus Lacerda, Dhélio B. Pereira, Allex Jardim da Fonseca, Ricardo Queiroz Gurgel, Ivo Castelo-Branco Coelho, Cor Jésus Fernandes Fontes, Ernesto T. A. Marques, Gustavo Adolfo Sierra Romero, Mauro Martins Teixeira, André Machado Siqueira, Aldina Maria Prado Barral, Viviane Sampaio Boaventura, Fabiano Ramos, Erivaldo Elias Júnior, José Cássio de Moraes, Dimas Tadeu Covas, Jorge Kalil, Alexander Roberto Precioso, Stephen S. Whitehead, Alejandra Esteves-Jaramillo, Tulin Shekar, Jungjin Lee, Julieta Macey, Sabrina Gozlan Kelner, Beth-Ann Coller, Fernanda Castro Boulos, Maurício Lacerda Nogueira · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2301790 · 被引用次数：205 · 研究领域：Mosquito-borne diseases and control、Viral Infections and Outbreaks Research、Biological Research and Disease Studies

BACKGROUND: Butantan-Dengue Vaccine (Butantan-DV) is an investigational, single-dose, live, attenuated, tetravalent vaccine against dengue disease, but data on its overall efficacy are needed. METHODS: In an ongoing phase 3, double-blind trial in Brazil, we randomly assigned participants to receive Butantan-DV or placebo, with stratification according to age (2 to 6 years, 7 to 17 years, and 18 to 59 years); 5 years of follow-up is planned. The objectives of the trial were to evaluate overall vaccine efficacy against symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination (the primary efficacy end point), regardless of serostatus at baseline, and to describe safety up to day 21 (the primary safety end point). Here, vaccine efficacy was assessed on the basis of 2 years of follow-up for each participant, and safety as solicited vaccine-related adverse events reported up to day 21 after injection. Key secondary objectives were to assess vaccine efficacy among participants according to dengue serostatus at baseline and according to the dengue viral serotype; efficacy according to age was also assessed. RESULTS: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) - 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and ...