A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa

NCT00123968 Phase 1/Phase 2 COMPLETED

The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	326
Start date	2006-05
Completion	2012-06

Conditions

• HIV Infections

Interventions

• VRC-HIVDNA016-00-VP
• VRC-HIVADV014-00-VP
• VRC-DILUENT013-DIL-VP
• VRC-HIVADV014-00-VP placebo

Primary outcomes

• Local reactogenicity signs and symptoms — Throughout study
• Systemic reactogenicity signs and symptoms — Throughout study
• Laboratory measures of safety — Throughout study
• Adverse and serious adverse experiences — Throughout study
• Unfractionated IFN-gamma ELISPOT responses to HIV-1 — At Day 196
• CD4+ and CD8+ T cell responses to HIV-1, as measured by flow cytometry-based intracellular cytokine staining (ICS) assay — At Day 196

Countries

Kenya, Tanzania, Uganda