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About
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
Enrollment
Sex
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Volunteers
Inclusion criteria
Participant with documented human immunodeficiency virus (HIV) infection who fulfill all of the following:
Participants have had tuberculosis (TB) preventive therapy (TPT) in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators
Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests
Capable of giving signed informed consent and informed assent (if appropriate), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or informed assent form, and in the protocol.
Female participants of childbearing potential must agree not to become pregnant from the time of study enrollment for one year after study intervention. Women physically capable of pregnancy, sexually active and having no history of hysterectomy or tubal ligation or menopause must agree to use an effective method of avoiding pregnancy during this period.
Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study.
Exclusion criteria
Acute illness or fever ≥99.5°F (or ≥37.5˚C) on Day 1
History of active TB disease
Evidence of active TB disease with any of the following:
Evidence and/or history of clinically significant medical conditions (other than HIV infection) as judged by the investigator, including malignancies
Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
Any medications or other therapies that may impact the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with major organ toxicity as determined by the investigator, within 90 days prior to Day 1
Immunosuppressive agents including systemic steroids - prior corticosteroid therapy within 90 days prior to Day 1 (permitted: 5 mg/day prednisone equivalent, inhaled, topical, and intra-articular corticosteroids)
Receipt or donation of blood or blood products within 90 days prior to Day 1 or planned receipt or donation during the study period
Participation in an interventional clinical trial and/or receipt of any investigational drug within 180 days prior to signing informed consent or assent
Receipt of any vaccine in the period starting 7 days before, and ending 7 days after, each dose of the study vaccine
History of previous administration of experimental Mycobacterium tuberculosis vaccine
Safety laboratory values outside of normal range, for age and sex that are suggestive of a disease state (Grade 1 abnormalities, as per Division of AIDS [DAIDS] toxicity table version 2.1, will not lead to exclusion if the investigator considers them not clinically significant.)
Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
Current hepatitis B and/or hepatitis C infection
Indeterminate QFT result
History of allergy or hypersensitivity to the study drug, excipients or related substances
Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB, e.g., Xpert MTB/RIF assay-positive, polymerase chain reaction (PCR)-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB
Female participants with any one of the following conditions: currently pregnant or lactating/nursing; having positive serum pregnancy test during the screening window, planning a pregnancy within 1 year after first dose of study product
Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel.
Child in Care
Primary purpose
Allocation
Interventional model
Masking
402 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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