H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults

Summary

The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.

Timeline

Start

2006-03

Primary completion

2007-03

Completion

2007-03

Publications

• Results Brady RC, Treanor JJ, Atmar RL, Keitel WA, Edelman R, Chen WH, Winokur P, Belshe R, Graham IL, Noah DL, Guo K, Hill H. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults. Vaccine. 2009 Aug 13;27(37):5091-5. doi: 10.1016/j.vaccine.2009.06.057. Epub 2009 Jul 3.

Drugs

Indications