NCT02375256

A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402

A Phase I, Double-Blind, Randomized, Placebo-controlled Leukapheresis Study to Obtain Lymphocytes for the Study of Immune Responses in Healthy Adult Volunteers in the U.S. Who Receive BCG Vaccination Followed by Boosting With AERAS-402

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days.

Detailed description

This was a double-blind, randomized, placebo-controlled study. At least 13, but no more than 16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG (1-8 x 105 colony forming units \[CFU\] intradermally \[ID\]) at Study Day -84. Thirteen of the BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to receive study vaccine (either AERAS-402 3 x 1010 virus particles \[vp\] intramuscularly \[IM\] or placebo IM) at Study Days 0 and 28, based on time of completion of screening. Eleven subjects were randomized (N=9 AERAS-402; N=2 placebo) and analyzed. Enrollment was stopped when 11 of the planned 13 subjects had been randomized, as it was felt that this number of subjects was sufficient to address the objectives of the study.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	AERAS-402	Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).
BIOLOGICAL	Placebo	Identical buffer solution in which AERAS-402 is formulated.
BIOLOGICAL	BCG (1-8 x105 cfu ID)	BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2013-12-01
• First posted: 2015-03-02
• Last updated: 2015-03-03