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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Beijing Ditan Hospital of Capital Medical University
Beijing, China
RECRUITINGOccurrence, intensity and relationship to vaccination of local and systemic adverse events
To evaluate the safety and tolerance of a replication defective adenovirus expressing HIV-1 gag in HIV-1 infected subjects on highly active antiretroviral therapy.
Time frame: 12 months
Immunogenicity of vaccine
To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.
Time frame: 24 month
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