An observer blinded, randomized, placebo-controlled, phase I dose escalation trial to evaluate the safety and immunogenicity of an inactivated West Nile virus Vaccine, HydroVax-001, in healthy adults
Year: 2019
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background West Nile virus (WNV) is the most common mosquito-borne infection in the United States. HydroVax-001 WNV is a hydrogen peroxide inactivated, whole virion (WNV-Kunjin strain) vaccine adjuvanted with aluminum hydroxide. Methods We performed a phase 1, randomized, placebo-controlled, double-blind (within dosing group), dose escalation clinical trial of the HydroVax-001 WNV vaccine administered via intramuscular injection. This trial evaluated 1 mcg and 4 mcg dosages of HydroVax-001 WNV vaccine given intramuscularly on day 1 and day 29 in healthy adults. The two dosing groups of HydroVax-001 were enrolled sequentially and each group consisted of 20 individuals who received HydroVax-001 and 5 who received placebo. Safety was assessed at all study days (days 1, 2, 4 and 15 post dose 1, and days 1, 2, 4, 15, 29, 57, 180 and 365 post dose 2), and reactogenicity was assessed for 14 days after administration of each dose. Immunogenicity was measured by WNV-specific plaque reduction neutralization tests (PRNT 50 ) in the presence or absence of added complement or by WNV-specific enzyme-linked immunosorbent assays (ELISA). Results HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT 50 but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added complement, PRNT 50 seroconversion rates increased to 50%, and 75% seroconversion was observed by WNV-specific ELISA. Conclusions The HydroVax-001 WNV vaccine was found to be modestly immunogenic and well-tolerated at all dose levels.
Source: Vaccine
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,450
Funders: U.S. Department of Health and Human Services, Pfizer, GlaxoSmithKline, Sanofi, Oregon Health and Science University, Department of Health and Human Services, State Government of Victoria, Novavax, Georgia Clinical and Translational Science Alliance, National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases
OpenAlex ID: W2909859336