title: Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine.
abstract: Butantan Institute is a public Brazilian biomedical research-manufacturer center affiliated to the São Paulo State Secretary of Health. Currently, Butantan is one of the main public producers of vaccines, antivenoms, and antitoxins in Latin America. The partnership between Butantan and the National Institutes of Health (NIH) of the United Sates has been one of the longest and most successful partnerships in the development and manufacturing of new vaccines. Recently, Butantan Institute has developed and manufactured a lyophilized tetravalent live attenuated dengue vaccine with the four dengue viruses attenuated and licensed from the Laboratory of Infectious Diseases at The National Institutes of Allergy and Infectious Diseases (LID/NIAID/NIH). The objective of this paper is to describe the clinical evaluation strategies of a live attenuated tetravalent dengue vaccine (Butantan-DV) developed and manufactured by Butantan Institute. These clinical strategies will be used to evaluate the Butantan-DV Phase III trial to support the Butantan-DV licensure for protection against any symptomatic dengue caused by any serotype in people aged 2 to 59 years.
authors.affiliation: Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil; Pediatrics Department of the School of Medicine of University of Sao Paulo, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.
authors.forename: Alexander Roberto
authors.initials: AR
authors.lastname: Precioso
authors.affiliation: Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Palacios
authors.affiliation: Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Thomé
authors.affiliation: Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Mondini
authors.affiliation: Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
authors.forename: Patrícia
authors.initials: P
authors.lastname: Braga
authors.affiliation: Butantan Institute, São Paulo, Brazil; Clinical Immunology and Allergy Division, University of São Paulo, São Paulo, Brazil.
authors.forename: Jorge
authors.initials: J
authors.lastname: Kalil
mesh_terms: D001938:Brazil; D002986:Clinical Trials as Topic; D003715:Dengue / Q000453:epidemiology / Q000517:prevention & control*; D053059:Dengue Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification*; D006801:Humans; D014613:Vaccines, Attenuated / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification
chemical_list: D053059:Dengue Vaccines; D014613:Vaccines, Attenuated
keywords: Butantan Institute; Clinical trial; Tetravalent dengue vaccine