Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine Clinical Trial
Official title:
Phase 1, Double Blind, Randomized, Placebo Controlled Study to Assess Safety and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults.
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal
powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of
age who are eligible for study participation will be enrolled in the trial. It is expected
that 10 subjects will be screened to obtain 7 subjects who will be eligible for study
participation.
The primary objective is to determine the frequency and severity of local and systemic
adverse events of vaccine.
The secondary objective is to assess the immunogenicity of the vaccine based on geometric
mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
n/a