Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP Administered Alone or Administered as a Boost to a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, in Uninfected Adult Volunteers in Uganda|
- Local reactogenicity signs and symptoms [ Time Frame: Measured through Day 336 ] [ Designated as safety issue: Yes ]
- Systemic reactogenicity signs and symptoms [ Time Frame: Measured through Day 336 ] [ Designated as safety issue: Yes ]
- Laboratory measures of safety [ Time Frame: Measured through Day 336 ] [ Designated as safety issue: Yes ]
- Adverse and serious adverse experiences [ Time Frame: Measured through Day 336 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: VRC-HIVADV014-00-VP Vaccine
All participants will receive one injection of the study vaccine (VRC-HIVADV014-00-VP) in their upper arm at study entry.
Biological: VRC-HIVADV014-00-VP Vaccine
All participants will receive one injection in their upper arm of 1 x 10^10 particle units (PU)/mL of VRC-HIVADV014-00-VP at study entry.
RV 156A is a single site, phase 1 open label study with accrual restricted to participants in RV 156. Participants in the RV 156 study were randomly assigned to receive three injections of either placebo or the VRC-HIVDNA009-00-VP vaccine. All participants in this study will receive one injection of a different experimental HIV vaccine, VRC-HIVADV014-00-VP. The purpose of this study is to evaluate the safety and immunogenicity of the VRC-HIVADV014-00-VP vaccine in people who participated in the RV 156 study. Researchers will examine the differences in the immune response to the VRC-HIVADV014-00-VP vaccine between people who received placebo in the RV 156 study and people who received the VRC-HIVDNA009-00-VP vaccine in the RV 156 study.
A projected number of up to 29 volunteers will be enrolled from the Makerere University site in Uganda. At study entry, all participants will undergo a physical examination, medical history review, vital sign measurements, and blood and urine collection. They will also receive counseling for HIV prevention and pregnancy prevention. Participants will then receive one injection of the VRC-HIVADV014-00-VP vaccine in their upper arm. They will remain in the clinic for 30 to 45 minutes for observation and monitoring. For 3 days after the vaccination, participants will record their temperature and any adverse symptoms in a diary. Additional study visits will occur at Days 3, 14, 28, 42, 84, 168, 252, and 336. At each visit, participants will undergo the same study procedures that they completed at the study entry visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549509
|Makerere University Walter Reed Project (MUWRP)|
|Principal Investigator:||Fred Wabwire-Mangen, MBChB, PhD||Makerere University Walter Reed Project|