New Dengue Vaccine Trial in Latin America Demonstrates Efficacy

Gustavo Dayan, MD Director, Clinical Development Sanofi Pasteur Discovery Drive Swiftwater, PA 18370 MedicalResearch.com Interview with:
Gustavo Dayan, MD

Director, Clinical Development
Sanofi Pasteur Discovery Drive
Swiftwater, PA 18370

Medical Research: What is the background for this study? What are the main findings?

Dr. Dayan: This is the first dengue vaccine efficacy trial conducted in Latin America. The trial met its primary objective showing an efficacy of 60.8% against symptomatic VCD (virologically confirmed dengue) after a 3-dose vaccination schedule. Serotype-specific efficacy was also demonstrated against all four serotypes. Furthermore, the dengue vaccine candidate effectively reduced hospitalization due to dengue by 80.3% and severe dengue disease by 95.5% over the 25-month study period.

Medical Research: What should clinicians and patients take away from your report?

Dr. Dayan: These study findings are consistent with those reported from a second large-scale efficacy trial of the vaccine candidate conducted in Asia. Together, the documented efficacy of this dengue vaccine candidate shows that dengue can be prevented through vaccination.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Dayan: It is important to ensure that all 4 serotypes circulate during the trial to be able to show efficacy against disease caused by each serotype. For this reason a variety of settings should be included in the trials. The inclusion of several settings in 5 countries in different hemispheres was key to ensure circulation of the 4 serotypes and to assess efficacy against each serotype.

Citation:

Luis Villar, M.D., Gustavo Horacio Dayan, M.D., José Luis Arredondo-García, M.D., Doris Maribel Rivera, M.D., Rivaldo Cunha, M.D., Carmen Deseda, M.D., Humberto Reynales, M.D., Maria Selma Costa, M.D., Javier Osvaldo Morales-Ramírez, M.D., Gabriel Carrasquilla, M.D., Luis Carlos Rey, M.D., Reynaldo Dietze, M.D., Kleber Luz, M.D., Enrique Rivas, M.D., Maria Consuelo Miranda Montoya, M.D., Margarita Cortés Supelano, M.D., Betzana Zambrano, M.D., Edith Langevin, M.Sc., Mark Boaz, Ph.D., Nadia Tornieporth, M.D., Melanie Saville, M.B., B.S., and Fernando Noriega, M.D. for the CYD15 Study Group

N Engl J Med 2015; 372:113-123
January 8, 2015
DOI: 10.1056/NEJMoa1411037