Evaluating the Safety and Immunogenicity of MTBVAC (NCT05947890) | Clinical Trial Compass
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
South Africa276 participantsStarted 2024-01-30
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
Who can participate
Age range
12 Years – 55 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
. Negative HIV-1 and -2 blood test: Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations
. Assessed by the clinic staff as having a low likelihood of acquiring HIV and is committed to maintaining behavior that is consistent with a lower likelihood of acquiring HIV through the last required protocol clinic visit
. Willingness to discuss their potential for HIV acquisition and is amenable to HIV risk reduction counseling
. For both Cohorts 2 and 3: Completed one course of tuberculosis preventive treatment (TPT) as determined by the site investigator.
. For Cohort 2: WHO HIV clinical stage 1 or 2 prior to initiation (or re-initiation in case of treatment interruption/default) of ART.
. Must agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 10 weeks after vaccination.
. Volunteers of pregnancy potential must also agree not to seek pregnancy through alternative methods, such as artificial insemination, or in vitro fertilization until 10 weeks after vaccination.
. Volunteers of pregnancy potential must also agree not to undergo oocyte retrieval.
Exclusion criteria
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
Number of unsolicited adverse events
Timeframe: Through study week 48
2
Number of solicited adverse events
Timeframe: Through study week 16
3
Number of Grade 3 or higher adverse events
Timeframe: Through study week 48
4
Number of serious adverse events
Timeframe: Through study week 48
5
Frequency and response of MTBVAC-reactive CD4+ cells expressing Th1 and/or Th17 cytokines
Timeframe: At baseline and study weeks 4
6
Frequency and response of MTBVAC-reactive CD4+ cells expressing Th1 and/or Th17 cytokines
Timeframe: At baseline and study weeks10
7
Frequency and response of MTBVAC-reactive CD8+ T cells expressing Th1 and/or Th17 cytokines
. A process that would affect the immune response,
. A process that would require medication that affects the immune response,
. Any contraindication to repeated injections or blood draws,
. A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
. A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
. Any condition specifically listed among the exclusion criteria below.
. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently \< 140 mm Hg systolic and \< 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be \< 140 mm Hg systolic and \< 90 mm Hg diastolic at enrollment.
. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
Frequency and response of MTBVAC-reactive CD8+ T cells expressing Th1 and/or Th17 cytokines