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<p>In individuals with prior dengue virus (DENV) exposure, subsequent heterotypic infection can increase the risk of severe disease. A single-dose dengue vaccine that protects against the four DENV serotypes across a wide age range and regardless of DENV serostatus is needed. Here we report the long-term safety and efficacy of Butantan dengue vaccine (Butantan-DV), a live, attenuated, tetravalent dengue vaccine, among participants ages 2–59 who were randomized 2:1 in a double-blind, placebo-controlled, phase 3 trial in Brazil. A primary objective was to evaluate vaccine efficacy (VE) against reverse transcription–PCR-positive symptomatic dengue 28 days after vaccination because of any DENV serotype, regardless of serostatus. Prespecified secondary endpoints included VE by serotype, by serostatus and against severe dengue or dengue with warning signs (combined). The primary and secondary objectives were met if the lower bound of the two-sided 95% confidence interval (CI) for VE was above 25%. Between 2016 and 2019, 16,235 participants received Butantan-DV (<i>n</i> = 10,259) or placebo (<i>n</i> = 5,976). The trial met the primary and secondary objectives. During the 5 years of follow-up, between 2016 and 2024, overall VE (95% CI) was 65.0% (57.8–71.0%). Secondary VE endpoints (95% CI) were 77.1% (67.6–83.9%) in dengue-experienced participants, 58.9% (48.0–67.6%) in dengue-naive participants, 73.0% (64.3–79.7%) against DENV-1 and 55.7% (42.3–66.1%) against DENV-2. Cases of DENV-3 or DENV-4 were not observed. VE (95% CI) against dengue with warning signs or severe dengue (secondary endpoint) was 80.5% (50.8–92.4%). The most commonly reported solicited systemic adverse event (AE) was headache (36.7% of vaccine recipients and 31.1% of placebo recipients), most of which were grade 1. The proportions of participants with unsolicited vaccine-related AEs (including serious AEs) were comparable between intervention groups. A single dose of Butantan-DV was efficacious against symptomatic virologically confirmed dengue because of DENV-1 or DENV-2, regardless of dengue serostatus at baseline, with no safety concerns observed during the 5-year follow-up (ClinicalTrials.gov: <a href="https://clinicaltrials.gov/study/NCT02406729">NCT02406729</a>).</p>

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Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine

  • 期刊论文

  • 发表日期：

    2026年3月4日

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  • Esper G. Kallás,
  • José A. Moreira,
  • Elizabeth G. Patiño,
  • Patricia Emilia Braga,
  • Juliana C. V. Tenório,
  • Lucas Bassolli de Oliveira Alves,
  • Vanessa Infante,
  • Daniela Haydee Ramos Silveira,
  • João Luiz Miraglia,
  • Monica A. T. Cintra,
  • Dhelio Batista Pereira,
  • Allex Jardim da Fonseca,
  • Ricardo Queiroz Gurgel,
  • Ivo Castelo-Branco Coelho,
  • Cor Jesus Fernandes Fontes,
  • Ernesto T. A. Marques,
  • Gustavo Adolfo Sierra Romero,
  • Mauro Martins Teixeira,
  • André M. Siqueira,
  • Viviane Sampaio Boaventura,
  • Fabiano Ramos,
  • Erivaldo Elias Júnior,
  • José Cassio de Moraes,
  • Cássia Fernanda Estofolete,
  • Angela Carvalho Freitas,
  • Cecilia Luiza Simoes dos Santos,
  • Maria do Carmo S. T. Timenetsky,
  • Stephen S. Whitehead,
  • Anna P. Durbin,
  • Alejandra Esteves-Jaramillo,
  • Tulin Shekar,
  • Jung-Jin Lee,
  • Qiuxu Chen,
  • Julieta Macey,
  • Sanskruti Vaidya,
  • Beth-Ann G. Coller,
  • Fernanda Castro Boulos,
  • Mauricio L. Nogueira,
  • Marcus Vínicius Guimarães de Lacerda

摘要

In individuals with prior dengue virus (DENV) exposure, subsequent heterotypic infection can increase the risk of severe disease. A single-dose dengue vaccine that protects against the four DENV serotypes across a wide age range and regardless of DENV serostatus is needed. Here we report the long-term safety and efficacy of Butantan dengue vaccine (Butantan-DV), a live, attenuated, tetravalent dengue vaccine, among participants ages 2–59 who were randomized 2:1 in a double-blind, placebo-controlled, phase 3 trial in Brazil. A primary objective was to evaluate vaccine efficacy (VE) against reverse transcription–PCR-positive symptomatic dengue 28 days after vaccination because of any DENV serotype, regardless of serostatus. Prespecified secondary endpoints included VE by serotype, by serostatus and against severe dengue or dengue with warning signs (combined). The primary and secondary objectives were met if the lower bound of the two-sided 95% confidence interval (CI) for VE was above 25%. Between 2016 and 2019, 16,235 participants received Butantan-DV (n = 10,259) or placebo (n = 5,976). The trial met the primary and secondary objectives. During the 5 years of follow-up, between 2016 and 2024, overall VE (95% CI) was 65.0% (57.8–71.0%). Secondary VE endpoints (95% CI) were 77.1% (67.6–83.9%) in dengue-experienced participants, 58.9% (48.0–67.6%) in dengue-naive participants, 73.0% (64.3–79.7%) against DENV-1 and 55.7% (42.3–66.1%) against DENV-2. Cases of DENV-3 or DENV-4 were not observed. VE (95% CI) against dengue with warning signs or severe dengue (secondary endpoint) was 80.5% (50.8–92.4%). The most commonly reported solicited systemic adverse event (AE) was headache (36.7% of vaccine recipients and 31.1% of placebo recipients), most of which were grade 1. The proportions of participants with unsolicited vaccine-related AEs (including serious AEs) were comparable between intervention groups. A single dose of Butantan-DV was efficacious against symptomatic virologically confirmed dengue because of DENV-1 or DENV-2, regardless of dengue serostatus at baseline, with no safety concerns observed during the 5-year follow-up (ClinicalTrials.gov: NCT02406729).