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Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults
Esper G Kallás1, Monica A T Cintra1, José A Moreira1
1From Instituto Butantan (E.G.K., M.A.T.C., J.A.M., E.G.P., P.E.B., J.C.V.T., V.I., R.P., D.T.C., J.K., A.R.P., F.C.B.), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (E.G.K.), Departamento de Saúde Coletiva, Faculdade de Ciências Médicas Santa Casa de São Paulo (J.C.M.), and Departamento de Clínica Médica, Faculdade de Medicina, Universidade de São Paulo (J.K.), São Paulo, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus (M.V.G.L.), Centro de Pesquisa em Medicina Tropical de Rôndonia, Porto Velho (D.B.P.), Universidade Federal de Roraima, Boa Vista (A.J.F.), Programa de Pós-graduação em Ciências da Saúde, Universidade Federal de Sergipe, Aracaju (R.Q.G.), Faculdade de Medicina da Universidade Federal do Ceará, Fortaleza (I.C.-B.C.), Hospital Universitário Júlio Müller, Cuiabá (C.J.F.F.), Institute Aggeu Magalhães, Fundação Oswaldo Cruz, Recife (E.T.A.M.), Núcleo de Medicina Tropical, Faculdade de Medicina, Universidade de Brasília, Brasília (G.A.S.R.), the Center for Advanced and Innovative Therapies, Universidade Federal de Minas Gerais, Belo Horizonte (M.M.T.), Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro (A.M.S.), Medicina e Saúde Pública de Precisão, Fundação Oswaldo Cruz-Instituto Gonçalo Moniz (IGM/FIOCRUZ), Salvador (A.M.P.B., V.S.B.), Hospital São Lucas da Pontificia Universidade Católica do Rio Grande do Sul, Porto Alegre (F.R.), Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul, Campo Grande (E.E.J.), Faculdade de Medicina de Ribeirão Preto, Universidade of São Paulo, Ribeirão Preto (D.T.C.), and Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto (M.L.N.) - all in Brazil; the School of Public Health, University of Pittsburgh, Pittsburgh (E.T.A.M.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (S.S.W.); Merck, Rahway, NJ (A.E.-J., T.S., J.-J.L., S.G.K., B.-A.G.C.); Merck Sharp and Dohme, Munro, Argentina (J.M.); and the Department of Pathology, University of Texas Medical Branch, Galveston (M.L.N.).
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 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure. Vaccine efficacy 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, regardless 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.).
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