Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
|ClinicalTrials.gov Identifier: NCT01017536|
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : October 13, 2014
Last Update Posted : September 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV Infections||Biological: AERAS-402 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2012|
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.
- CD4+ Lymphocyte Count [ Time Frame: CD4+ counts from samples collected on Study days 0 and 182. ]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) Change in cells/mm^3 pre-vaccination to Study Day 182
- Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182) [ Time Frame: 6 months (day 182) post Study Day 0 vaccination. ]
- Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease [ Time Frame: Study days 28 and 56 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017536
|Klerksdorp, North-West, South Africa, 2570|
|Principal Investigator:||Gavin Churchyard, MD, PhD||Aurum Institute|
|Study Director:||Bernard Landry, MPH||Aeras|