TuberculosisPhase 1/2NCT05539989
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa
A Phase 1/2 study testing VPM1002 Vaccine and BCG Vaccine in people with Tuberculosis and HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 9 sites in South Africa.
Trial summary
The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis (M.tb) sensitization. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, HIV Infections
- What is being tested?
- VPM1002 Vaccine and BCG Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 9 sitesSouth Africa
- Study dates
- 31 Dec 2026to 31 Dec 2026
- Phase
- Phase 1/2
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian is willing and able to provide written informed consent; when applicable potential participant is willing and able to provide written assent
- Age 8-14 years (inclusive) at entry
- Received birth dose of BCG vaccine
- Has a negative nucleic acid test result for M.tb at screening and no other evidence of current active TB disease at screening
- M.tb sensitization status (positive or negative) determined based on IGRA testing at screening
- HIV status determined
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- For participants living with HIV: has been receiving antiretroviral therapy for at least six months prior to study entry, has a CD4+ cell count of at least 200 cells/mm^3 at screening, has had a suppressed HIV viral load for at least three months prior to entry
- Has normal or grade 1 results for all of the following at screening: Hemoglobin, White blood cell count, Platelet count, Creatinine, ALT, AST, Total bilirubin
- Has a normal temperature and no signs or symptoms of acute illness
- For participants assigned female sex at birth or who could otherwise become pregnant: not pregnant
- For participants assigned female sex at birth or who could otherwise breastfeed: not breastfeeding
- Expected to be available for 48 weeks of study participation
- Not expected to participate in any other study of an investigational agent during the 48 weeks of study participation
Who cannot join
- Known significant exposure to TB or receipt of tuberculin skin test in the six months prior to study entry
- Receipt of treatment for active TB disease in the 24 months prior to study entry
- Receipt of TB preventive therapy within 30 days prior to study entry or expected to initiate TB preventive therapy within the 48 weeks following study entry
- For participants living with HIV, current active AIDS-defining condition
- Receipt of any of the following: Any investigational TB vaccine, More than 14 consecutive days of systemic immunosuppressants or other immune-modifying therapy within the six months prior to study entry, Any immunoglobulin or other blood product within the three months prior to study entry,
- Receipt of any vaccine within the 30 days prior to study entry or is expected to receive any vaccine between study entry and the Week 4 Visit
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- Receipt of allergy treatment with an antigen injection within the 30 days prior to study entry or is expected to receive one or more antigen injections between study entry and the Week 48 Visit
- History of any of the following: serious adverse reaction to any vaccine, allergy or hypersensitivity to BCG vaccine, allergy or hypersensitivity to the components of VPM1002 vaccine, anaphylaxis, generalized urticaria, autoimmune disease, diabetes mellitus type 1 or type 2, mild persistent, moderate, or severe asthma, bleeding disorder, malignancy, any condition resulting in the absence of a functional spleen (asplenia), including but not limited to sickle cell disease
- History of seizure or use of any medication to prevent or treat seizure within the three years prior to entry
- History of suspected or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnosed within the 30 days prior to entry
- Any other documented or suspected clinically significant medical, psychiatric, or behavioral condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Africa9 sites
Desmond Tutu TB Centre - Stellenbosch University (SU) CRS
Cape Town, Western Cape
Emavundleni CRS
Cape Town, Western Cape
Umlazi CRS
Durban
Soweto IMPAACT CRS
Johannesburg, Gauteng, 1862
Wits RHI Shandukani Research CRS
Johannesburg
Klerksdorp CRS
Klerksdorp, North West
Setshaba Research Centre CRS
Soshanguve, Gauteng
Isipingo CRS
Soshanguve, KwaZulu-Natal
Family Clinical Research Unit (FAM-CRU) CRS
Tygerberg Hills
About this study
Official title: Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against Tuberculosis in Pre-Adolescents Living With and Without HIV in South Africa
The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis (M.tb) sensitization.
Read the detailed description
Phase I/II, double-blinded, placebo-controlled, randomized (1:1:1) multi-center study. Randomization will be stratified by HIV status and M.tb sensitization status. The study will enroll approximately 480 pre-adolescents (8-14 years of age inclusive) with or without HIV and with or without M.tb sensitization who received BCG vaccination at birth. Participants with HIV will be immunocompetent and virologically suppressed on antiretroviral therapy.
Participants will be randomized to one of three study product arms: VPM1002 Vaccine, BCG Vaccine, or Placebo. Each participant will receive a single intradermal injection of the assigned study product.
- Conditions
- Tuberculosis, HIV Infections
- Being tested
- VPM1002 Vaccine, BCG Vaccine, Placebo
- Keywords
- Bacterial and fungal diseases, Tuberculosis, Vaccine, Live vaccine, rBCG
- Medical subject headings
- Tuberculosis, HIV Infections, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPM1002 VaccineBiological
0.1 mL (2-8x10^5 CFU)
BCG VaccineBiological
0.1mL (0.075 Mycobacterium bovis)
PlaceboDrug
0.1 mL (sodium chloride for injection 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| VPM1002 Vaccine Arm | Experimental | Participants stratified by HIV and M.tb sensitization status. Receives: Biological: VPM1002 Vaccine |
| BCG Vaccine Arm | Experimental | Participants stratified by HIV and M.tb sensitization status. Receives: Biological: BCG Vaccine |
| Placebo Arm | Placebo comparator | Participants stratified by HIV and M.tb sensitization status. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All adverse events
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 48
Solicited adverse events
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 16
Grade 3 or higher adverse events
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 48
Serious adverse events
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 48
Adverse pregnancy outcomes
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Measured by ICS and flow cytometry on cryopreserved PBMCs
Measured: Through Week 10
Secondary outcomes (9)
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Measured by ICS and flow cytometry on cryopreserved PBMC
Measured: Weeks 24 and 48
Mycobacteria-specific IgA, IgG, and IgM binding antibodies
Measured using BAMA
Measured: Entry and Weeks 4, 10, 24, and 48
Association of HIV and IGRA with primary safety outcomes (All AEs, solicitated AEs, grade 3 or higher AEs, serious adverse events, adverse pregnancy outcomes).
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
Cellular immunogenicity outcome measures associated with HIV and IGRA status
VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines, measured by ICS and flow cytometry on cryopreserved PBMCs
Measured: Through Week 48
Humoral immunogenicity outcome measures associated with HIV and IGRA status
Mycobacteria-specific IgA, IgG, and IgM binding antibodies, measured using BAMA
Measured: Through Week 48
Gene expression profiles
Measured by RNA-seq in whole blood
Measured: Entry and Weeks 1, 4, and 10
Differential leukocyte count and immunophenotype
Measured in cryopreserved ex vivo whole blood (DLC-ICE) by flow cytometry
Measured: Entry and Weeks 1, 4, and 10
Measurement of soluble proinflammatory mediators
Based on serum measurement
Measured: Entry and Weeks 1, 4, and 10
Acceptability of the study products
Based on scores derived from questionnaire responses
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: The study is no longer moving forward due to the changing TB vaccine landscape.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lisa Marie Cranmer, MD, MPH, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539989
- Sponsor's protocol ID
- IMPAACT 2035/HVTN 604
- Other IDs
- UM1AI068632, UM1AI068616, UM1AI106716, HHSN275201800001I
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against Tuberculosis in Pre-Adolescents Living With and Without HIV in South Africa
- ClinicalTrials.gov ID
- NCT05539989
- Acronym / sponsor ID
- IMPAACT 2035/HVTN 604
- Conditions
- Tuberculosis, HIV Infections
- Keywords
- Bacterial and fungal diseases, Tuberculosis, Vaccine, Live vaccine, rBCG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is no longer moving forward due to the changing TB vaccine landscape.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2022 (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 purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis (M.tb) sensitization.
Detailed description
Phase I/II, double-blinded, placebo-controlled, randomized (1:1:1) multi-center study. Randomization will be stratified by HIV status and M.tb sensitization status. The study will enroll approximately 480 pre-adolescents (8-14 years of age inclusive) with or without HIV and with or without M.tb sensitization who received BCG vaccination at birth. Participants with HIV will be immunocompetent and virologically suppressed on antiretroviral therapy.
Participants will be randomized to one of three study product arms: VPM1002 Vaccine, BCG Vaccine, or Placebo. Each participant will receive a single intradermal injection of the assigned study product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VPM1002 Vaccine Arm | Experimental | Biological: VPM1002 VaccineParticipants stratified by HIV and M.tb sensitization status. |
| BCG Vaccine Arm | Experimental | Biological: BCG VaccineParticipants stratified by HIV and M.tb sensitization status. |
| Placebo Arm | Placebo comparator | Drug: PlaceboParticipants stratified by HIV and M.tb sensitization status. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Parent or legal guardian is willing and able to provide written informed consent; when applicable potential participant is willing and able to provide written assent
- Age 8-14 years (inclusive) at entry
- Received birth dose of BCG vaccine
- Has a negative nucleic acid test result for M.tb at screening and no other evidence of current active TB disease at screening
- M.tb sensitization status (positive or negative) determined based on IGRA testing at screening
Key exclusion criteria (11 listed)
- Known significant exposure to TB or receipt of tuberculin skin test in the six months prior to study entry
- Receipt of treatment for active TB disease in the 24 months prior to study entry
- Receipt of TB preventive therapy within 30 days prior to study entry or expected to initiate TB preventive therapy within the 48 weeks following study entry
- For participants living with HIV, current active AIDS-defining condition
- Receipt of any of the following: Any investigational TB vaccine, More than 14 consecutive days of systemic immunosuppressants or other immune-modifying therapy within the six months prior to study entry, Any immunoglobulin or other blood product within the three months prior to study entry,
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 Vaccine0.1 mL (2-8x10^5 CFU) | Biological | VPM1002 Vaccine Arm |
| BCG Vaccine0.1mL (0.075 Mycobacterium bovis) | Biological | BCG Vaccine Arm |
| Placebo0.1 mL (sodium chloride for injection 0.9%) | Drug | Placebo Arm |
Primary outcome
All adverse events
Time frame: Through Week 48
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Solicited adverse events
Time frame: Through Week 16
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Grade 3 or higher adverse events
Time frame: Through Week 48
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Serious adverse events
Time frame: Through Week 48
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Adverse pregnancy outcomes
Time frame: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
Proportion of participants, based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Time frame: Through Week 10
Measured by ICS and flow cytometry on cryopreserved PBMCs
9 secondary outcomes
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Time frame: Weeks 24 and 48
Mycobacteria-specific IgA, IgG, and IgM binding antibodies
Time frame: Entry and Weeks 4, 10, 24, and 48
Association of HIV and IGRA with primary safety outcomes (All AEs, solicitated AEs, grade 3 or higher AEs, serious adverse events, adverse pregnancy outcomes).
Time frame: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
Cellular immunogenicity outcome measures associated with HIV and IGRA status
Time frame: Through Week 48
Humoral immunogenicity outcome measures associated with HIV and IGRA status
Time frame: Through Week 48
Gene expression profiles
Time frame: Entry and Weeks 1, 4, and 10
Differential leukocyte count and immunophenotype
Time frame: Entry and Weeks 1, 4, and 10
Measurement of soluble proinflammatory mediators
Time frame: Entry and Weeks 1, 4, and 10
Acceptability of the study products
Time frame: Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
Lisa Marie Cranmer, MD, MPH study chair
Emory University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VPM1002 Vaccine and BCG Vaccine in people with Tuberculosis and HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 9 sites in South Africa.
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 11 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: withdrawn, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
All adverse events (time frame: Through Week 48). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.