Mycobacterium Tuberculosis InfectionPhase 3VPM1002NCT04351685
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
A Phase 3 study testing VPM1002 and BCG SII in people with Mycobacterium Tuberculosis Infection, run by Serum Institute of India Pvt. Ltd. at 12 sites in 5 countries.
Trial summary
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection. Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Tuberculosis Infection
- What is being tested?
- VPM1002 and BCG SII
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,940 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 9 Nov 2020to 30 Oct 2024
- Phase
- Phase 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 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A Maternal
- Age: 18 years or older at screening.
- Willing to comply with the trial protocol, available and willing to allow her child to complete all the trial assessments and must have signed an Informed Consent form that has been approved by respective Site Ethics Committee.
- No symptoms or signs of active TB at the time of participant's enrolment.
- Parent / guardian who intends to remain in the trial area with the child should be reachable by phone during the trial period.
- For HIV-unexposed group: Test negative for HIV within two months prior to the newborn infant's vaccination. Test result must be documented, in absence of which a HIV test must be performed at the infant screening visit.
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- For the HIV-exposed group: Test positive for HIV and test result must be documented. If documentation is missing, a HIV test must be performed at the screening visit. The newborn infant's mother must have enrolled for standard antiretroviral therapy (ART) at least 2 months before the participant's birth
- No participation in an interventional clinical trial within 3 months prior to the participant's birth. In addition, if mother is breast-feeding then she must not participate in another clinical trial during the current trial period while breastfeeding.
- B Infant
- Healthy male or female newborn infant.
- Birth weight of at least 2,300 g.
- Test negative for HIV by PCR at screening if born to an HIV-infected mother.
- No participation in an interventional clinical trial prior to enrolment. Participant should not take part in another clinical trial for the duration of the current trial period.
Who cannot join
- A Maternal
- Any reported or suspected substance abuse during pregnancy.
- House-hold contact with active TB (defined as residing in the same house as an individual with active TB) within the 3 months prior to enrolment.
- B Infant
- Fever at the time of enrolment.
- Eczema or other significant skin lesion or infection at the site/s of injection as per protocol.
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- Receipt of routine BCG vaccine (as per vaccination record).
- Clinically suspected sepsis.
- Clinically suspected sepsis.
- Any malignant condition.
- Any clinically significant severe congenital malformation, which may interfere with the evaluation of the safety, efficacy or immunogenicity of the vaccine.
- Concomitant treatment with medication that may significantly affect immune function (e.g. systemic corticoids, immunosuppressive drugs) before trial vaccination. (Note: Routine medication given at birth such as topical antibiotics for eye care and vitamins A and K are permitted. In HIV-exposed newborn infants prevention of mother-to-child transmission (PMTCT) based on standard of care is allowed, but must be documented.)
- Receipt of blood products or immunoglobulin before trial vaccination.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
South Africa5 sites
Family Center for Research with Ubuntu
Cape Town, 7505
Empilweni Services and Research Unit (ESRU)
Johannesburg, Coronation Ville, 2093
Mecru Clinical Research Unit
Medunsa, 0204
Respiratory and Meningeal Pathogens Research Unit
Soweto, 2013
South African Tuberculosis Vaccine Initiative
Worcester, 6850
Kenya2 sites
Kenya Medical Research Institute / Center for Respiratory Disease Research
Nairobi, 47855-00100
Kenya Medical Research Institute - Center for Respiratory Disease Research
Siaya, 144
Tanzania2 sites
Ifakara Health Institute
Dar es Salaam, 61665
The national institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC)
Mbeya, Mbeya, 2410
Uganda2 sites
Medical Research Council / Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines (MRC/UVRI and LSHTM) Uganda Research Unit
Entebbe
Makerere University/CISMAC
Kampala, 7062
About this study
Official title: A Multicenter, Phase III, Double-blind, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.
Read the detailed description
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.
Healthy male or female newborn infants will be centrally randomized to receive the allocated vaccine, stratified by the HIV status of the mother. Single dose of VPM1002 or BCG SII will be administered (within 14 days of birth) strictly intradermally.
- Conditions
- Mycobacterium Tuberculosis Infection
- Being tested
- VPM1002, BCG SII
- Keywords
- Bacterial and fungal diseases
- Medical subject headings
- Tuberculosis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPM1002Biological
The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally.
Manufactured by the Serum Institute of India Pvt. Ltd., India
Diluent: 1 ml of Water for injection/vial
BCG SIIBiological
Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally.
Manufactured by the Serum Institute of India Pvt. Ltd., India
Diluent: 1 ml of Sodium Chloride for injection/vial Injection
| Study group | Role | What they receive |
|---|---|---|
| VPM1002 | Experimental | Total 3470 subjects will be enrolled in VPM1002 arm.
Single dose of VPM1002 will be administered. Receives: Biological: VPM1002 |
| BCG SII | Active comparator | Total 3470 subjects will be enrolled in BCG SII arm.
Single dose of BCG SII will be administered. Receives: Biological: BCG SII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident cases of QFT conversion, indicating Mtb infection
Measured: Minimum of 12 months and maximum of 36 months
Secondary outcomes (1)
The rate of TB disease in children receiving VPM1002 compared to BCG SII. Incident cases of sustained QFT conversion, indicating sustained Mtb infection.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start9 Nov 2020
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium Tuberculosis InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serum Life Science Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Dr Prasad Kulkarni, MD, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351685
- Sponsor's protocol ID
- VPM1002-MN-3.05TB
- Acronym
- VPM1002
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nduba V, Mathebula M, Nankabirwa V, Dempster M, Mhimbira F, Sabi I, Wajja A, Cotton MF, Barnabas S, Adegnika AA, Kaufmann SHE, Bruckner S, May M, Hoss CW, Revathy M, Niranjan V, Bhargava A, Gupta M, Kapse D, Desai S, Grode L, Kulkarni PS, Shaligram U; priMe consortium. Comparison of VPM1002 with BCG in the prevention of tuberculosis in newborn infants: a multicentre, double-blind, randomised, phase 3, non-inferiority trial. Lancet Infect Dis. 2026 Aug 18:S1473-3099(26)00374-9. doi: 10.1016/S1473-3099(26)00374-9. Online ahead of print.
PubMed 42612668Giersing 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase III, Double-blind, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants
- ClinicalTrials.gov ID
- NCT04351685
- Acronym / sponsor ID
- VPM1002 / VPM1002-MN-3.05TB
- Conditions
- Mycobacterium Tuberculosis Infection
- Keywords
- Bacterial and fungal diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,940 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Serum Life Science Europe GmbH
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 17 Apr 2020 (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.
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.
Detailed description
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.
Healthy male or female newborn infants will be centrally randomized to receive the allocated vaccine, stratified by the HIV status of the mother. Single dose of VPM1002 or BCG SII will be administered (within 14 days of birth) strictly intradermally.
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 | Experimental | Biological: VPM1002Total 3470 subjects will be enrolled in VPM1002 arm. Single dose of VPM1002 will be administered. |
| BCG SII | Active comparator | Biological: BCG SIITotal 3470 subjects will be enrolled in BCG SII arm. Single dose of BCG SII will be administered. |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- A Maternal
- Age: 18 years or older at screening.
- Willing to comply with the trial protocol, available and willing to allow her child to complete all the trial assessments and must have signed an Informed Consent form that has been approved by respective Site Ethics Committee.
- No symptoms or signs of active TB at the time of participant's enrolment.
- Parent / guardian who intends to remain in the trial area with the child should be reachable by phone during the trial period.
Key exclusion criteria (13 listed)
- A Maternal
- Any reported or suspected substance abuse during pregnancy.
- House-hold contact with active TB (defined as residing in the same house as an individual with active TB) within the 3 months prior to enrolment.
- B Infant
- Fever at the time of enrolment.
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 |
|---|---|---|
| VPM1002The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally. Manufactured by the Serum Institute of India Pvt. Ltd., India Diluent: 1 ml of Water for injection/vial | Biological | VPM1002 |
| BCG SIICommercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally. Manufactured by the Serum Institute of India Pvt. Ltd., India Diluent: 1 ml of Sodium Chloride for injection/vial Injection | Biological | BCG SII |
Primary outcome
Incident cases of QFT conversion, indicating Mtb infection
Time frame: Minimum of 12 months and maximum of 36 months
1 secondary outcome
The rate of TB disease in children receiving VPM1002 compared to BCG SII. Incident cases of sustained QFT conversion, indicating sustained Mtb infection.
Time frame: 36 Months
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 10 Feb 2025.
- Derived from this study: PubMed 42612668Nduba V, Mathebula M, Nankabirwa V, Dempster M, Mhimbira F, Sabi I, Wajja A, Cotton MF, Barnabas S, Adegnika AA, Kaufmann SHE, Bruckner S, May M, Hoss CW, Revathy M, Niranjan V, Bhargava A, Gupta M, Kapse D, Desai S, Grode L, Kulkarni PS, Shaligram U; priMe consortium. Comparison of VPM1002 with BCG in the prevention of tuberculosis in newborn infants: a multicentre, double-blind, randomised, phase 3, non-inferiority trial. Lancet Infect Dis. 2026 Aug 18:S1473-3099(26)00374-9. doi: 10.1016/S1473-3099(26)00374-9. Online ahead of print.
- 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
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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.
Dr Prasad Kulkarni, MD study director
Serum Institute of India Pvt. Ltd.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VPM1002 and BCG SII in people with Mycobacterium Tuberculosis Infection, run by Serum Institute of India Pvt. Ltd. at 12 sites in 5 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 13 inclusion and 13 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Africa, Kenya, Tanzania, Uganda, Gabon. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Incident cases of QFT conversion, indicating Mtb infection (time frame: Minimum of 12 months and maximum of 36 months). 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 NCT04351685, which also lists 2 linked publications.
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 10 Feb 2025.