Clinical Trial Info

Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

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The Phase 1/2 study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation.

The eligible 2000 participants will be randomized in 1:1 ratio to receive a single dose of either VPM1002 or a placebo. After study vaccination, participants will be followed up for one year. Any suspected TB case during follow-up will be further evaluated and bacteriologically confirmed. Study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. SAEs will be recorded and reported throughout study participation.