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 (C013404)
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This was a Phase I double-blind, randomized, placebo-controlled study in 70 subjects. This study was conducted in HIV-negative, TB-negative, healthy adults who are BCG-naïve at study entry. This study was conducted in Lausanne, Switzerland where BCG vaccination is no longer part of the standard immunization schedule. Seventy adults received BCG SSI at Day 42 and AERAS-404 (ug H4: nmol IC31) on Day 0, Day 56, and/or Day 231 as a 3- (N=30) or 2-dose (N=30) regimen; follow-up for 28 days.
| Group | Day -42 (dose) | Day 0 (dose) | Day 56 (dose) | Day 231 (dose) |
|---|---|---|---|---|
| 1 | BCG SSI (2-8 x 10^5 cfu) | Placebo | Placebo | Placebo |
| 2 | BCG SSI (2-8 x 10^5 cfu) | Placebo | AERAS-404 (50:500) | AERAS-404 (50:500) |
| 3 | BCG SSI (2-8 x 10^5 cfu) | AERAS-404 (50:500) | AERAS-404 (50:500) | AERAS-404 (50:500) |
Assess the safety of BCG and a 2- or 3-dose regimen of AERAS-404 administered to HIV-negative, TB-negative, BCG-naive adults.
AERAS-404 (50:500 given IM as 2 or 3 doses to healthy adults with the first dose given at 6 or 14 weeks after BCG) was associated with an acceptable safety profile.
CHUV (Lausanne, Switzerland)
https://clinicaltrials.gov/show/NCT02420444
Jan. 17, 2011
May 7, 2012