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The study has the following objectives:
Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.
Full description
Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).
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39 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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