Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine in Flavivirus-Naive Infants
V. Watanaveeradeja b, S. Simasathien, A. Nisalak, T. Endy, R. Jarman, B. Innis, Stephen J. Thomas, R. Gibbons, S. Hengprasert, R. Samakoses, A. Kerdpanich, D. Vaughn, J. Putnak, K. Eckels, Rafael A. De La Barrera, M. Mammen✉
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Abstract
A Phase I/II observer-blind, randomized, controlled trial evaluated the safety and immunogenicity of a dengue virus (DENV) vaccine candidate in healthy Thai infants (aged 12-15 months) without measurable pre-vaccination neutralizing antibodies to DENV and Japanese encephalitis virus. Fifty-one subjects received two doses of either DENV (N = 34; four received 1/10th dose) or control vaccine (N = 17; dose 1, live varicella; dose 2, Haemophilus influenzae type b). After each vaccine dose, adverse events (AEs) were solicited for 21 days, and non-serious AEs were solicited for 30 days; serious AEs (SAEs) were recorded throughout the study. Laboratory safety assessments were performed at 10 and 30 days; neutralizing antibodies were measured at 30 days. The DENV vaccine was well-tolerated without any related SAEs. After the second dose, 85.7% of full-dose DENV vaccinees developed at least trivalent and 53.6% developed tetravalent neutralizing antibodies ≥ 1:10 to DENV (control group = 0%). This vaccine candidate, therefore, warrants continued development in this age group (NCT00322049; clinicaltrials.gov).
TL;DRThis vaccine candidate, therefore, warrants continued development in this age group (NCT00322049; clinicaltrials.gov), and was well-tolerated without any related SAEs. (Semantic Scholar)