Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy(HAART) .
Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (2×10^9VP, 2×10^10VP or 2×10^11VP) injections of Adenovirus vector vaccine (Ad5-gag). Two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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