H5 Vaccine Alone or With Adjuvant in Healthy Adults

Summary

This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved in study related procedures for up to 8 months.

Timeline

Start

2006-03

Primary completion

2006-12

Completion

2006-12

Publications

• Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, Noah DL, Hill H. Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial. J Infect Dis. 2008 Nov 1;198(9):1309-16. doi: 10.1086/592172.

Drugs

Indications