Precioso Alexander Roberto, Palacios Ricardo, Thomé Beatriz, Mondini Gabriella, Braga Patrícia, Kalil Jorge
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.
Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
Vaccine. 2015 Dec 10;33(50):7121-5. doi: 10.1016/j.vaccine.2015.09.105. Epub 2015 Oct 14.
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.
布坦坦研究所是巴西一家隶属于圣保罗州卫生部的公共生物医学研究与生产中心。目前，布坦坦是拉丁美洲主要的疫苗、抗蛇毒血清和抗毒素公共生产商之一。布坦坦与美国国立卫生研究院（NIH）之间的合作关系，是新型疫苗研发与生产领域中持续时间最长且最为成功的合作关系之一。最近，布坦坦研究所研发并生产了一种冻干四价减毒活登革热疫苗，该疫苗所含的四种登革热病毒是经美国国立过敏与传染病研究所（LID/NIAID/NIH）传染病实验室减毒并获得许可的。本文旨在描述布坦坦研究所研发生产的四价减毒活登革热疫苗（布坦坦-DV）的临床评估策略。这些临床策略将用于评估布坦坦-DV三期试验，以支持布坦坦-DV获得许可，用于预防2至59岁人群中由任何血清型引起的任何有症状登革热。
