NCT01017536

Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Further study details as provided by Aeras.

Conditions

• Tuberculosis
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	Placebo	Placebo was the identical buffer solution in which AERAS-402 is formulated.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2009-11-20
• Last updated: 2016-09-09
• Results posted: 2014-10-13

Locations

1 site across 1 country: South Africa