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NCT06062238
Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults
Conditions: Tuberculosis
Sex: All
Ages: 15 Years – 44 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 20080
Sponsor: Gates Medical Research Institute
Location: 2201-Gates MRI Investigational Site Bandung
Summary
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.
Eligibility Criteria
Inclusion criteria:
* Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant's parent, or legally authorized representative (LAR) will be required to sign a statement of informed consent, in addition to the minor's signed statement of assent.
* In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and return for follow-up visits).
* Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety.
* Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial.
* Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator.
* Negative sputum Xpert Ultra or similar assay result at screening.
* Both males and females are included. Females are included with restrictions. Females must either be of non-childbearing potential, defined as pre-menarche, have a history of either current tubal ligation, hysterectomy, or ovariectomy, or post-menopause, or, if she is of childbearing potential, she has practiced abstinence from penile-vaginal intercourse or adequate contraception for 28 days prior to vaccination, has a negative pregnancy test on the day of screening and the day of first vaccination, and agrees to continue abstinence or adequate contraception until 2 months after the second dose of trial intervention.
* HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only).
* HIV Cohort only: Participants with documented HIV infection who fulfill all of the following criteria:
1. Have reactive anti-HIV antibody at screening.
2. Have been on antiretroviral therapy (ART) for at least 3 consecutive months at screening and agree to remain on ART throughout the trial.
3. Have documented HIV Ribonucleic acid (RNA) \
Source: ClinicalTrials.gov (NCT06062238). StuddyBuddy aggregates publicly available trial information.