Journal
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Volume 96, Issue 6, Pages 1325-1337Publisher
AMER SOC TROP MED & HYGIENE
DOI: 10.4269/ajtmh.16-0634
Keywords
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Funding
- U.S. Army Medical Research and Materiel Command
- Military Infectious Diseases Research Program
- GlaxoSmithKline Biologicals SA
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The safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 mu g with aluminum hydroxide (alum) or at 1 mu g with an adjuvant system (AS01(E) or AS03(B)), were evaluated in a first-time-in-human, placebo-controlled, randomized, observer-blind, phase 1 trial in the continental United States. Two doses of vaccine or placebo were administered intramuscularly 4 weeks apart to 100 healthy adults 18-39 years of age, randomized 1: 1: 1: 1: 1 to receive one of four DPIV formulations or saline placebo. The response to a third dose was evaluated in a subset of nine participants remote from primary vaccination. Humoral immunogenicity was assessed using a 50% microneutralization assay. All DPIV formulations were well tolerated. No vaccine-related serious adverse events were observed through 12 months after the second vaccine dose. In all DPIV groups, geometric mean antibody titers peaked at Day 56, waned through 6 months after the second vaccine dose, and then stabilized. In the nine subjects where boosting was evaluated, a strong anamnestic response was observed. These results support continuation of the clinical development of this dengue vaccine candidate (clinicaltrials.gov: NCT01666652).
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