July 2015

Efficacy And Long-Term Safety Of A Dengue Vaccine In Regions Of Endemic Disease

PUBLICATION

Background

A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian–Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.

Methods

We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57. We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15.

Funded by Sanofi Pasteur; ClinicalTrials.gov numbers, NCT00842530, NCT01983553, NCT01373281, and NCT01374516.

Authors

Sri Rezeki Hadinegoro, M.D., Ph.D., Jose Luis Arredondo-García, M.D., Maria Rosario Capeding, M.D., Carmen Deseda, M.D., Tawee Chotpitayasunondh, M.D., Reynaldo Dietze, M.D., H.I. Hj Muhammad Ismail, M.B., B.S., Humberto Reynales, M.D., Ph.D., Kriengsak Limkittikul, M.D., Doris Maribel Rivera-Medina, M.D., Huu Ngoc Tran, M.D., Ph.D., Alain Bouckenooghe, M.D., Danaya Chansinghakul, M.D., Margarita Cortés, M.D., Karen Fanouillere, M.Sc., M.P.H., Remi Forrat, M.D., Carina Frago, M.D., Sophia Gailhardou, Pharm.D., Nicholas Jackson, Ph.D., Fernando Noriega, M.D., Eric Plennevaux, Ph.D., T. Anh Wartel, M.D., Betzana Zambrano, M.D., and Melanie Saville, M.B., B.S. for the CYD-TDV Dengue Vaccine Working Group

Read the study: Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease – NEJM http://www.nejm.org/doi/full/10.1056/NEJMoa1506223