Abstract |
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 (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).
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Authors | Alexander C Schmidt, Leyi Lin, Luis J Martinez, Richard C Ruck, Kenneth H Eckels, Alix Collard, Rafael De La Barrera, Kristopher M Paolino, Jean-François Toussaint, Edith Lepine, Bruce L Innis, Richard G Jarman, Stephen J Thomas |
Journal | The American journal of tropical medicine and hygiene
(Am J Trop Med Hyg)
Vol. 96
Issue 6
Pg. 1325-1337
(Jun 2017)
ISSN: 1476-1645 [Electronic] United States |
PMID | 28719287
(Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Adjuvants, Immunologic
- Alum Compounds
- Antibodies, Viral
- Dengue Vaccines
- Vaccines, Inactivated
- aluminum sulfate
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Topics |
- Adjuvants, Immunologic
(chemistry)
- Adolescent
- Adult
- Alum Compounds
(chemistry)
- Antibodies, Viral
(blood)
- Dengue
(immunology, prevention & control)
- Dengue Vaccines
(administration & dosage, therapeutic use)
- Dengue Virus
(isolation & purification)
- Dose-Response Relationship, Drug
- Female
- Humans
- Male
- Single-Blind Method
- United States
- Vaccination
- Vaccines, Inactivated
(administration & dosage, therapeutic use)
- Young Adult
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