drugset / Trial / NCT02375256

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

NCT02375256

Phase 1 Completed 11 enrolled Aeras
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2009-10
Primary completion
2010-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AERAS-402 Vaccine 3e+10 unknown Intramuscular
Background BCG Vaccine 100000 unknown Other

Indications