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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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