• Pio López, Claudio F Lanata, Betzana Zambrano, Margarita Cortés, Teresa Andrade, Isabel Amemiya, Cynthia Terrones, Ana I Gil, Hector Verastegui, Viviana Marquez, Denis Crevat, John Jezorwski, and Fernando Noriega.
• From the *Centro de Estudios en Infectología Pediátrica, Cali, Colombia; †Instituto de Investigación Nutricional, Lima, Perú; ‡Clinical Development, Sanofi Pasteur, Montevideo, Uruguay; §Clinical Development, Sanofi Pasteur, Marcy l'Etoile, France; and ¶Clinical Development, Sanofi Pasteur, Swiftwater, Pennsylvania.
• Pediatr. Infect. Dis. J. 2016 Oct 1; 35 (10): 1140-7.

BackgroundDengue and yellow fever (YF) viruses are closely related members of the Flaviviridae family. Given the inherent similarities between the YF vaccine and dengue vaccine (CYD-TDV) candidate, it is possible that the latter could interfere with the response to the licensed YF vaccine when coadministered.MethodsIn this randomized, observer-blind, controlled, phase III trial, conducted in Colombia and Peru, 787 toddlers were administered YF vaccine concomitantly with CYD-TDV (group 1) or placebo (group 2), followed by CYD-TDV after 6 and 12 months. YF and dengue neutralizing antibody titers were determined using a 50% plaque reduction neutralization test. Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval of the difference in seroconversion rates [(YF + CYD-TDV) - YF alone] was greater than -10%. The safety of both vaccines was also assessed.ResultsConcomitant administration of YF with either CYD-TDV or placebo yielded YF seroconversion rates of 100.0% and 99.7%, respectively. The difference in YF seroconversion rates between the 2 groups was 0.33% (95% confidence interval:0.98; 1.87), demonstrating that the immune response against YF administered concomitantly with CYD-TDV was noninferior to YF administered with placebo. After 2 injections of CYD-TDV, the percentage of participants with dengue titres ≥10 (1/dil) for the 4 dengue serotypes were 91.2%-100% for group 1 and 97.2%-100% in group 2. There were no safety concerns during the study period.ConclusionsConcomitant administration of YF vaccine with CYD-TDV has no relevant impact on the immunogenicity or safety profile of the YF vaccine.

19 keywords...

hide…