Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4·5-year results from a phase 3, randomised, double-blind, placebo-controlled trial

作者：Vianney Tricou, Delia Yu, Humberto Reynales, Shibadas Biswal, Xavier Sáez‐Llorens, Chukiat Sirivichayakul, Pío López, Charissa Borja-Tabora, Lulu Bravo, Pope Kosalaraksa, Luis Martinez Vargas, Maria Theresa Alera, Luis Rivera, Veerachai Watanaveeradej, Reynaldo Dietze, LakKumar Fernando, Pujitha Wickramasinghe, Edson Duarte Moreira, Asvini D. Fernando, Dulanie Gunasekera, Kléber Giovanni Luz, Ana Oliveira, Suely Tuboi, Ian Escudero, Yanee Hutagalung, Eric Lloyd, Martina Rauscher, Olaf Zent, Nicolas Folschweiller, Inge Lefevre, Félix Espinoza, Derek Wallace · 发表于：The Lancet Global Health · 年份：2024 · DOI：10.1016/s2214-109x(23)00522-3 · 被引用次数：255 · 研究领域：Mosquito-borne diseases and control、Viral Infections and Outbreaks Research、Parasitic Diseases Research and Treatment

BACKGROUND: About half of the world's population lives in dengue-endemic areas. We aimed to evaluate the long-term efficacy and safety of two doses of the tetravalent dengue vaccine TAK-003 in preventing symptomatic dengue disease of any severity and due to any dengue virus (DENV) serotypes in children and adolescents. METHODS: In this ongoing double-blind, randomised, placebo-controlled trial, we enrolled healthy participants aged 4-16 years at 26 medical and research centres across eight dengue-endemic countries (Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). The main exclusion criteria were febrile illness (body temperature ≥38°C) at the time of randomisation, hypersensitivity or allergy to any of the vaccine components, pregnancy or breastfeeding, serious chronic or progressive disease, impaired or altered immune function, and previous receipt of a dengue vaccine. Participants were randomly assigned 2:1 (stratified by age and region) using an interactive web response system and dynamic block assignment to receive two subcutaneous doses of TAK-003 or placebo 3 months apart. Investigators, participants, and their parents or legal guardians were blinded to group assignments. Active febrile illness surveillance and RT-PCR testing of febrile illness episodes were performed for identification of virologically confirmed dengue. Efficacy outcomes were assessed in the safety analysis set (all randomly assigned participants who recei...