NCT02420444

A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults

A Phase I Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of BCG and AERAS-404 Administered as a Prime-Boost Regimen to HIV-Negative, TB-Negative, BCG-Naive Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and followed through Study Day 259.

Detailed description

A total of 70 subjects who had received BCG at Study Day -42 were randomized on Study Day 0 to receive 3 doses of placebo (N=10); 1 dose of placebo followed by 2 doses of AERAS-404 (N=30; AERAS-404 2 dose regimen); or 3 doses of AERAS-404 (N=30; AERAS-404 3 dose regimen). A total of 69 (98.6%) subjects completed the study; the remaining subject, in the AERAS-404 2 dose regimen, withdrew consent. All 70 subjects received the first and second vaccinations with placebo or AERAS-404 on Study Days 0 and 56, and 67 (95.7%) subjects received the third vaccination on Study Day 231. Three subjects did not receive the Study Day 231 vaccination (2 in the AERAS-404 2 dose regimen, 1 due to withdrawal of consent and 1 due to pregnancy \[the subject delivered a healthy boy without complications and was followed to study completion\]; and 1 in the AERAS-404 3 dose regimen, due to inability to discontinue daily isotretinoin started after the second vaccination \[the subject was followed to study completion\]).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	BCG SSI	The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.
BIOLOGICAL	Placebo	This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.
BIOLOGICAL	AERAS-404	AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2013-11-01
• First posted: 2015-04-17
• Last updated: 2017-01-24

Locations

1 site across 1 country: Switzerland