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 range12 Years – 55 Years
SexALL
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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
✕. 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.
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
Timeframe: At baseline and study weeks 4
8
Frequency and response of MTBVAC-reactive CD8+ T cells expressing Th1 and/or Th17 cytokines