Live, attenuated, tetravalent Butantan- Dengue vaccine in children and adults
Author
Butantan affiliation
External affiliation
(HC/HCFMUSP) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo ; (FCMSCSP) Faculdade de Ciências Médicas da Santa Casa de São Paulo ; (FMT-HVD) Fundação de Medicina Tropical Doutor Heitor Vieira Dourado ; (CEPEM) Centro de Pesquisa em Medicina Tropical ; (UFRR) Universidade Federal de Roraima ; (UFS) Universidade Federal de Sergipe ; (UFC) Universidade Federal do Ceará ; Hospital Universitário Júlio Müller ; (FIOCRUZ) Fundação Oswaldo Cruz ; (UNB) Universidade de Brasília ; (UFMG) Universidade Federal de Minas Gerais ; (INI) Instituto Nacional de Infectologia Evandro Chagas ; (PUC-RS) Pontifícia Universidade Católica do Rio Grande Do Sul ; (UFMS) Universidade Federal de Mato Grosso do Sul ; (USP) Universidade de São Paulo ; (FAMERP) Faculdade de Medicina de São José do Rio Preto ; University of Pittsburgh ; (NIH) National Institutes of Health ; (MSD) Merck Sharp and Dohme ; (UTMB) University of Texas Medical Branch
Publication type
Article
Language
English
Access rights
Restricted access
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Abstract
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 con firmed 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 effi cacy 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
89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure. Vaccine effi cacy was 80.1% (95% CI, 66.0 to 88.4) among participants 2 to 6 years of age, 77.8%
(95% CI, 55.6 to 89.6) among those 7 to 17 years of age, and 90.0% (95% CI, 68.2 to
97.5) among those 18 to 59 years of age. Efficacy against DENV-1 was 89.5% (95% CI,
78.7 to 95.0) and against DENV-2 was 69.6% (95% CI, 50.8 to 81.5). DENV-3 and
DENV-4 were not detected during the follow-up period. Solicited systemic vaccine- or
placebo-related adverse events within 21 days after injection were more common
with Butantan-DV than with placebo (58.3% of participants, vs. 45.6%).
CONCLUSIONS
A single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regard less of dengue serostatus at baseline, through 2 years of follow-up. (Funded by
Instituto Butantan and others; DEN-03-IB ClinicalTrials.gov number, NCT02406729,
and WHO ICTRP number, U1111-1168-8679.)
Link to cite this reference
https://repositorio.butantan.gov.br/handle/butantan/5248
URL
https://doi.org/10.1056/NEJMoa2301790
Journal title
Issue Date
2024
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