At a glance
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A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels
In Brief
A Phase 2 clinical trial evaluating Inactivated Influenza H1N1 vaccine for Influenza. Completed, enrolled 192 participants across 6 sites.
Detailed Summary
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.
Study Details
Timeline
Interventions
Two doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.