A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults — C-013-404  

Tuberculosis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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]). ;

Related Conditions & MeSH terms

• Tuberculosis

• NCT number: NCT02420444
• Study type: Interventional
• Source: Aeras
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Completion date: November 2013