NCT02762045

Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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) .

Detailed description

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.

Conditions

• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Ad5-gag	Ad5-gag is used as vaccine in all arms.
BIOLOGICAL	Placebo	Preservation Solution is used as control in all arms.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2016-05-04
• Last updated: 2016-05-04

Locations

1 site across 1 country: China