Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to a second group of 40 subjects was planned, but although no safety concerns were identified, the sponsor decided not to continue the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of AERAS-402 in HIV-infected, BCG-vaccinated Adults With CD4+ Lymphocyte Counts Greater Than 350 Cells/mm3|
- CD4+ Lymphocyte Count [ Time Frame: CD4+ counts from samples collected on Study days 0, 7, 14, 28, 35, 42, 56, 84, and 182. ] [ Designated as safety issue: Yes ]Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease)
- HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 [ Time Frame: 6 months (day 182) post Study Day 0 vaccination. ] [ Designated as safety issue: Yes ]
- Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease [ Time Frame: Study days 0, 7, 14, 28, 35, 42, 56, 84, and 182 ] [ Designated as safety issue: No ]Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools. TB10.4 response data are not shown due to minimal response.
|Study Start Date:||December 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Thirteen subjects received placebo vaccine that did not contain any AERAS-402.
Placebo was the identical buffer solution in which AERAS-402 is formulated.
Experimental: Investigational Vaccine
Thirteen subjects received active vaccine 3 x 10^10 vp AERAS-402.
AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Further study details as provided by Aeras.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017536
|Klerksdorp, North-West, South Africa, 2570|
|Principal Investigator:||Gavin Churchyard, MD, PhD||Aurum Institute|
|Study Director:||Bernard Landry, MPH||Aeras|