Trials / Completed
CompletedNCT03152903
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 2,000 (actual)
- Sponsor
- Serum Institute of India Pvt. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VPM1002 (Recombinant BCG Vaccine) | VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002. VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally. |
| OTHER | Placebo | Single dose of Placebo is administered intradermally. |
Timeline
- Start date
- 2017-12-15
- Primary completion
- 2023-12-29
- Completion
- 2023-12-29
- First posted
- 2017-05-15
- Last updated
- 2025-05-18
Locations
10 sites across 2 countries: Bangladesh, India
Source: ClinicalTrials.gov record NCT03152903. Inclusion in this directory is not an endorsement.