VPM1002 is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+.
VPM1002 is indicated to prevent tuberculosis recurrence
A single dose of VPM1002 or placebo will be administered to calculate the efficacy of the vaccine against TB recurrence.
Clinical Trial NCT03152903: Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence in India
- The 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 participants will be randomized in 1:1 ratio to receive single dose of either VPM1002 or 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.