Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus-naive infants

Am J Trop Med Hyg. 2011 Aug;85(2):341-51. doi: 10.4269/ajtmh.2011.10-0501.

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).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Dengue / prevention & control*
  • Dengue Vaccines / administration & dosage
  • Dengue Vaccines / adverse effects
  • Dengue Vaccines / immunology*
  • Encephalitis, Japanese / prevention & control
  • Humans
  • Immunization Schedule
  • Infant
  • Japanese Encephalitis Vaccines / immunology
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology

Substances

  • Dengue Vaccines
  • Japanese Encephalitis Vaccines
  • Vaccines, Attenuated

Associated data

  • ClinicalTrials.gov/NCT00322049