Prevention of TB RecurrencePhase 2/3NCT03152903
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
A Phase 2/3 study testing VPM1002 (Recombinant BCG Vaccine) in people with Prevention of TB Recurrence, run by Serum Institute of India Pvt. Ltd. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of TB Recurrence
- What is being tested?
- VPM1002 (Recombinant BCG Vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Dec 2017to 29 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Reactive serology for HIV
- History of extrapulmonary TB
- Known or suspected impairment of immunological function
- Pregnant and / or lactating female participants
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
India9 sites
MV Hopsital for Diabetes Pvt Ltd, Chennai
Chennai, Tamil Nadu, 600013
Sri Ramachandra Hospital Chennai
Chennai, Tamil Nadu, 600116
Mahavir Hospital & Research Centre, Hyderabad
Hyderabad, Andhra Pradesh, 500004
Government Medical College, Jammu
Jammu, Jammu and Kashmir, 180001
Christian Medical College and Hospital, Ludhiana
Ludhiana, Punjab, 141008
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Puducherry, Tamil Nadu, 605006
B.J. Govt. Medical College and Sassoon General Hospitals
Pune, Maharashtra, 411001
Mahatma Gandhi Institute of Medical Sciences, Sevagram
Sevāgrām, Maharashtra, 442102
Christian Medical College and Hospital, Vellore
Vellore, Tamil Nadu, 632004
Bangladesh1 site
International Centre for Diarrhoeal Disease Research
Dhaka, 1212
About this study
Official title: 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
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.
Read the 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
- Prevention of TB Recurrence
- Being tested
- VPM1002 (Recombinant BCG Vaccine), Placebo
- Keywords
- Recombinant BCG vaccine, Category 1 pulmonary tuberculosis, Recurrence, Efficacy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPM1002 (Recombinant BCG Vaccine)Biological
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.
PlaceboOther
Single dose of Placebo is administered intradermally.
| Study group | Role | What they receive |
|---|---|---|
| VPM1002 (Recombinant BCG vaccine) | Experimental | Not described Receives: Biological: VPM1002 (Recombinant BCG Vaccine) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of bacteriologically confirmed TB recurrence cases
Percentage of TB recurrence patients who have previously been successfully treated for TB, were declared cure and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination.
Measured: 2-12 months post-vaccination
Secondary outcomes (2)
Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)
Percentage of TB recurrence patients who have previously been successfully treated by for TB, were declared cure and are now diagnosed with a new episode of either bacteriologically confirmed or clinically diagnosed recurrent TB after at least 2 months from vaccination.
Measured: 2-12 months post-vaccination
Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs
- Solicited local and regional reactogenicity events within 2 months following study vaccination
- Unsolicited adverse events and SAEs throughout the study period
Measured: Throughout study participation i.e.12 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 Dec 2017
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of TB RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152903
- Sponsor's protocol ID
- VPM1002-IN-3.01TBR
- Status last verified
- May 2025
- First submitted
- 28 Apr 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giersing B, Mo AX, Hwang A, Baqar S, Earle K, Ford A, Deal C, Dull P, Friede M, Hall BF. Meeting summary: Global vaccine and immunization research forum, 2023. Vaccine. 2025 Feb 6;46:126686. doi: 10.1016/j.vaccine.2024.126686. Epub 2025 Jan 5.
PubMed 39752894
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03152903
- Acronym / sponsor ID
- VPM1002-IN-3.01TBR
- Conditions
- Prevention of TB Recurrence
- Keywords
- Recombinant BCG vaccine, Category 1 pulmonary tuberculosis, Recurrence, Efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VPM1002 (Recombinant BCG vaccine) | Experimental | Biological: VPM1002 (Recombinant BCG Vaccine) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Reactive serology for HIV
- History of extrapulmonary TB
- Known or suspected impairment of immunological function
- Pregnant and / or lactating female participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | VPM1002 (Recombinant BCG vaccine) |
| PlaceboSingle dose of Placebo is administered intradermally. | Other | Placebo |
Primary outcome
Percentage of bacteriologically confirmed TB recurrence cases
Time frame: 2-12 months post-vaccination
Percentage of TB recurrence patients who have previously been successfully treated for TB, were declared cure and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination.
2 secondary outcomes
Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)
Time frame: 2-12 months post-vaccination
Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs
Time frame: Throughout study participation i.e.12 months post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 39752894Giersing B, Mo AX, Hwang A, Baqar S, Earle K, Ford A, Deal C, Dull P, Friede M, Hall BF. Meeting summary: Global vaccine and immunization research forum, 2023. Vaccine. 2025 Feb 6;46:126686. doi: 10.1016/j.vaccine.2024.126686. Epub 2025 Jan 5.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VPM1002 (Recombinant BCG Vaccine) in people with Prevention of TB Recurrence, run by Serum Institute of India Pvt. Ltd. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India, Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bacteriologically confirmed TB recurrence cases (time frame: 2-12 months post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.