Title
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
Date Issued
24 September 2016
Access level
open access
Resource Type
journal article
Publisher(s)
Lippincott Williams and Wilkins
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% confdence 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% confdence 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 profle of the YF vaccine.
Start page
1140
End page
1147
Volume
35
Issue
10
Language
English
OCDE Knowledge area
Inmunología Medicina tropical
Scopus EID
2-s2.0-84973174672
PubMed ID
Source
Pediatric Infectious Disease Journal
ISSN of the container
08913668
Sources of information: Directorio de Producción Científica Scopus