1. Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Healthy Children and Adults in Dengue-Endemic Regions: A Randomized, Placebo-Controlled Phase 2 Study.
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Sirivichayakul, Chukiat, Barranco-Santana, Elizabeth A., Esquilin-Rivera, Inés, Oh, Helen M. L., Raanan, Marsha, Sariol, Carlos A., Shek, Lynette P., Simasathien, Sriluck, Smith, Mary Kathryn, Velez, Ivan Dario, Wallace, Derek, Gordon, Gilad S., and Stinchcomb, Dan T.
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SAFETY standards , *VACCINES , *BIOLOGICALS , *DENGUE , *ARBOVIRUS diseases , *SUBCUTANEOUS injections , *COMPARATIVE studies , *FLAVIVIRUSES , *IMMUNOGLOBULINS , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *SAFETY , *VIRAL antibodies , *EVALUATION research , *VIRAL vaccines , *RANDOMIZED controlled trials , *BLIND experiment , *STANDARDS , *PREVENTION - Abstract
Background: A safe, effective tetravalent dengue vaccine is a global health priority. The safety and immunogenicity of a live attenuated, recombinant tetravalent dengue vaccine candidate (TDV) were evaluated in healthy volunteers from dengue-endemic countries.Methods: This multicenter, double-blind, phase 2 study was conducted in Puerto Rico, Colombia, Singapore, and Thailand. During stage I, 148 volunteers aged 1.5-45 years were sequentially enrolled into 4 age-descending groups and randomized at a ratio of 2:1 to receive TDV or placebo. In stage II (group 5), 212 children aged 1.5-11 years were randomized at a ratio of 3:1 to receive TDV or placebo. Participants received a subcutaneous injection of TDV or placebo on days 0 and 90 and were followed for analysis of safety, seropositivity, and neutralizing antibodies to DENV-1-4.Results: Injection site pain, itching, and erythema (mostly mild) were the only solicited adverse events more frequently reported with TDV than with placebo in all age groups. After 2 TDV doses, seropositivity was >95% in all 5 groups for DENV-1-3 and 72.7%-100% for DENV-4; geometric mean titers ranged from 582 to 1187 for DENV-1, from 582 to 1187 for DENV-2, from 196 to 630 for DENV-3, and from 41 to 210 for DENV-4 among the 5 groups.Conclusions: TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure. [ABSTRACT FROM AUTHOR]- Published
- 2016
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