NCT03152903CompletedPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 2000 (actual)
- First submitted
- 28 Apr 2017
- Start date
- 15 Dec 2017
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Diseases
- Tuberculosis
- NCT number
- NCT03152903
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 2000
- From 15 Dec 2017 to the primary completion date, 29 Dec 2023
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Reactive serology for HIV
- History of extrapulmonary TB
- Known or suspected impairment of immunological function
Other
- Pregnant and / or lactating female participants
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| International Centre for Diarrhoeal Disease Research Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
| Sri Ramachandra Hospital Chennai Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| MV Hopsital for Diabetes Pvt Ltd, Chennai Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Mahavir Hospital & Research Centre - Hyderabad Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Government Medical College Jammu Coordinator of this site? Confirm its status | Jammu | India | Unknown status |
| Christian Medical College and Hospital, Ludhiana Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| B.J. Govt. Medical College and Sassoon General Hospitals Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Mahatma Gandhi Institute of Medical Sciences, Sevagram Coordinator of this site? Confirm its status | Sevāgrām | India | Unknown status |
| Christian Medical College and Hospital, Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.