Unknown

Dataset Information

0

Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States.


ABSTRACT: AbstractThe safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 ?g with aluminum hydroxide (alum) or at 1 ?g with an adjuvant system (AS01E or AS03B), 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).

SUBMITTER: Schmidt AC 

PROVIDER: S-EPMC5462566 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

altmetric image

Publications

Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States.

Schmidt Alexander C AC   Lin Leyi L   Martinez Luis J LJ   Ruck Richard C RC   Eckels Kenneth H KH   Collard Alix A   De La Barrera Rafael R   Paolino Kristopher M KM   Toussaint Jean-François JF   Lepine Edith E   Innis Bruce L BL   Jarman Richard G RG   Thomas Stephen J SJ  

The American journal of tropical medicine and hygiene 20170601 6


AbstractThe safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 μg with aluminum hydroxide (alum) or at 1 μg with an adjuvant system (AS01<sub>E</sub> or AS03<sub>B</sub>), 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 a  ...[more]

Similar Datasets

| S-EPMC5953365 | biostudies-literature
| S-EPMC9622737 | biostudies-literature
2022-04-13 | GSE146658 | GEO
| S-EPMC4385761 | biostudies-literature
| S-EPMC7204593 | biostudies-literature
| S-EPMC7356407 | biostudies-literature
| S-EPMC7644226 | biostudies-literature
| S-EPMC5049724 | biostudies-literature
| S-EPMC7410446 | biostudies-literature
| S-EPMC4559679 | biostudies-literature