Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine.

ABSTRACT:

Background

H5N1 avian influenza represents an episodic zoonotic disease with the potential to cause a pandemic, and antiviral resistance is of considerable concern. We sought to generate high-titer H5N1 antibodies in healthy volunteers for the purpose of developing hyperimmune intravenous immunoglobulin.

Methods

We conducted a dose-escalating, unblinded clinical trial involving 75 subjects aged 18-59 years. Three cohorts of twenty-five subjects were enrolled sequentially and received 90, 120, or 180 microg of H5N1 A/Vietnam/1203/04 vaccine in 4 doses administered approximately 28 days apart.

Results

No statistically significant dose-related increases in the geometric mean titers (GMTs) of serum hemagglutination inhibition antibody were observed when the 90-microg, 120

SUBMITTER: Beigel JH 

PROVIDER: S-EPMC3417327 | biostudies-literature | 2009 Aug

REPOSITORIES: biostudies-literature