CompletedPhase 2/3

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

Bangladesh, India2,000 participantsStarted 2017-12-15

Plain-language summary

This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Males or females aged ≥18 and ≤65 years.
✓. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level ≤7% and non-diabetics) who successfully completed ATT as per national guidelines.
✓. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
✓. Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.
✓. Participant must intend to remain in the area during the study period.

Exclusion criteria

✕. Reactive serology for HIV
✕. History of extrapulmonary TB
✕. Known or suspected impairment of immunological function
✕. Pregnant and / or lactating female participants

What they're measuring

Percentage of bacteriologically confirmed TB recurrence cases

Timeframe: 2-12 months post-vaccination

Trial details

NCT IDNCT03152903

SponsorSerum Institute of India Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-29

View on ClinicalTrials.gov More Prevention of TB Recurrence trials