Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescen… (NCT05539989) | Clinical Trial Compass
WithdrawnPhase 1/2
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa
Stopped: The study is no longer moving forward due to the changing TB vaccine landscape.
South Africa0Started 2025-12-31
Plain-language 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.
Who can participate
Age range
8 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* Known significant exposure to TB or receipt of tuberculin skin test in the six mont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All adverse events
Timeframe: Through Week 48
2
Solicited adverse events
Timeframe: Through Week 16
3
Grade 3 or higher adverse events
Timeframe: Through Week 48
4
Serious adverse events
Timeframe: Through Week 48
5
Adverse pregnancy outcomes
Timeframe: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
6
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Timeframe: Through Week 10
Trial details
NCT IDNCT05539989
SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group