Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril) When Administered Concomitantly With a Tetravalent Dengue Vaccine Candidate in Healthy Toddlers at 12–13 Months of Age in Colombia and Peru: A Randomized Trial. Issue 10 (October 2016)

• Record Type: Journal Article
• Authors: López, Pio; Lanata, Claudio F.; Zambrano, Betzana; Cortés, Margarita; Andrade, Teresa; Amemiya, Isabel; Terrones, Cynthia; Gil, Ana I.; Verastegui, Hector; Marquez, Viviana; Crevat, Denis; Jezorwski, John; Noriega, Fernando
• Is Part Of: Pediatric infectious disease journal. Volume 35:Issue 10(2016)
• Publication Date: 2016-10
• Subjects: vaccine -- safety -- immunogenicity -- yellow fever -- dengue; Communicable diseases in children -- Periodicals; Infection in children -- Periodicals; 618.929
• DOI: 10.1097/INF.0000000000001250
• Languages: English
• ISSNs: 0891-3668

Abstract

Abstract : Background: Dengue 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. Methods: In 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. Results: Concomitant 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. Conclusions: Concomitant administration of YF vaccine with CYD-TDV has no relevant impact on the immunogenicity or safety profile of the YF vaccine. Abstract : Supplemental Digital Content is available in the text.