Immunogenicity and Safety of a Recombinant Tetravalent Dengue Vaccine in Children and Adolescents Ages 9–16 Years in Brazil
Open Access
- 4 December 2013
- journal article
- research article
- Published by American Society of Tropical Medicine and Hygiene in The American Journal of Tropical Medicine and Hygiene
- Vol. 89 (6), 1058-1065
- https://doi.org/10.4269/ajtmh.13-0304
Abstract
Immunogenicity and safety of a recombinant, live-attenuated, tetravalent dengue disease vaccine (CYD-TDV) was evaluated in children/adolescents in Brazil. In this observer-blind, placebo-controlled, phase II single-center study, children/adolescents (ages 9–16 years) were randomized to receive CYD-TDV or placebo at 0, 6, and 12 months. Immunogenicity was assessed using a 50% plaque neutralization test. Overall, 150 participants were enrolled (CYD-TDV: N = 100; placebo: N = 50). Injection site pain and headache were the most common solicited injection site and systemic reactions. Unsolicited adverse events (AEs) and serious AEs were similar between groups. No serious AEs were vaccine-related. Geometric mean titers against all dengue virus serotypes increased with CYD-TDV vaccination and were 267, 544, 741, and 432 1/dil for serotypes 1–4, respectively, after dose 3, representing a mean fold increase from baseline of 5, 6, 6, and 20, respectively. CYD-TDV vaccination elicited a neutralizing antibody response against serotypes 1–4 and was well-tolerated in children/adolescents in a dengue-endemic region.Keywords
This publication has 28 references indexed in Scilit:
- Safety and Immunogenicity of a Recombinant Tetravalent Dengue Vaccine in 9–16 Year OldsThe Pediatric Infectious Disease Journal, 2013
- Optimization and Validation of a Plaque Reduction Neutralization Test for the Detection of Neutralizing Antibodies to Four Serotypes of Dengue Virus Used in Support of Dengue Vaccine DevelopmentThe American Journal of Tropical Medicine and Hygiene, 2013
- Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2–45 yearsHuman Vaccines & Immunotherapeutics, 2012
- DengueThe New England Journal of Medicine, 2012
- Dominant Cross-Reactive B Cell Response during Secondary Acute Dengue Virus Infection in HumansPLoS Neglected Tropical Diseases, 2012
- Priming Effect of Dengue and Yellow Fever Vaccination on the Immunogenicity, Infectivity, and Safety of a Tetravalent Dengue Vaccine in HumansThe American Journal of Tropical Medicine and Hygiene, 2011
- From research to phase III: Preclinical, industrial and clinical development of the Sanofi Pasteur tetravalent dengue vaccineVaccine, 2011
- Inferring the Serotype Associated with Dengue Virus Infections on the Basis of Pre‐ and Postinfection Neutralizing Antibody TitersThe Journal of Infectious Diseases, 2010
- The Epidemiology of Dengue in the Americas Over the Last Three Decades: A Worrisome RealityThe American Journal of Tropical Medicine and Hygiene, 2010
- Recent Shift in Age Pattern of Dengue Hemorrhagic Fever, BrazilEmerging Infectious Diseases, 2008