This was an open-label protocol in up to 18 healthy, BCG-naive adults. All participants were planned to receive a total of two doses of BCG, by intradermal injection, approximately 6 months apart and followed by a combination of visits and telephone contacts for approximately 8 months. Participants were planned to undergo tuberculin skin testing (TST) 2 months after the second BCG vaccination and QuantiFERON®-TB Gold in-Tube testing (QTBGT), or the equivalent. Two BCG vaccinations given 6 months apart were chosen for this study to give optimal T cell and antibody responses for future study. Leukapheresis was planned to be conducted prior to the first BCG vaccination and again approximately 56 days after the second BCG vaccination (Hoft, 2002; Brown, 2003; de Valliere, 2005). The final leukapheresis timing was selected based on results from functional biological assays, which suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG, and on results of prior clinical trials describing the peak immune responses to BCG (Hoft, 2002; Brown, 2003; de Valliere, 2005). The study was conducted at a single site in the US (SLU).

TICE® strain of Bacillus of Calmette and Guerin (BCG) 1 mL BCG was administered by intradermal injection on Study Day 0 and on Study Day 166 in different arms. BCG Lot numbers: N00Y809 and R000569 0.9% NaCl Lot number: 75-455-DK Sterile Water For Injection Lot Number: 660274P