Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|