A multicenter Phase II/ III double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of VPM1002 in the prevention of tuberculosis (TB) recurrence in pulmonary TB patients after successful TB treatment in India.

To evaluate the efficacy of VPM1002 in prevention of TB recurrence in former pulmonary TB patients who have successfully completed ATT and were declared cured. Secondary Objective To evaluate the safety of VPM1002 in former TB patients who have successfully completed ATT and were declared as cured. Exploratory Objective Storage of samples to allow future TB research such as:

To assess immunology and Transcriptomics as potential correlates of protection and/or Biomarkers in a subgroup of participants.

To perform microbiological evaluation of recurrence in a subgroup of recurrent TB patients (i.e. re-infection vs. relapse).

To compare immunological difference between VPM1002 and placebo groups.

To compare immunological difference between diabetic and non-diabetic participants.

To assess and compare TB mortality between VPM1002 and placebo groups

Study Endpoints (Outcome Variables)
Primary Endpoint

Bacteriologically confirmed recurrence cases: Number of recurrence patients who have previously been successfully treated for TB, were declared cured and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination.

Secondary Endpoints

Overall recurrence: Number of recurrence patients, who have previously been successfully treated for TB, were declared cured and are now diagnosed with a new episode of either bacteriologically confirmed or clinically diagnosed recurrent TB after at least 2 months from vaccination. Time to bacteriologically confirmed recurrent TB after at least 2 months from vaccination.