Therapeutic ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB

Launched by ADVANCING CLINICAL THERAPEUTICS GLOBALLY FOR HIV/AIDS AND OTHER INFECTIONS · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called ID93 + GLA-SE to see if it can improve treatment outcomes for people with pulmonary tuberculosis (TB) who are also living with HIV. The vaccine is experimental and has not yet been approved for regular use, but it has been tested in other research settings. Participants in the trial will receive either the vaccine or a placebo (an inactive substance) while they are undergoing standard TB treatment. The researchers aim to learn how different timing of the vaccine injections affects the body's immune response and to ensure the vaccine is safe for a larger group of people.

To join the study, participants must be between 18 and 65 years old, have confirmed rifampicin-susceptible pulmonary TB, and have a documented HIV status. They should be on HIV treatment if they are HIV positive. The trial is not yet recruiting participants, but when it begins, those who qualify will receive regular check-ups and injections over the course of the study. It's important for potential participants to know that they cannot be pregnant or breastfeeding, and they must meet specific health criteria to ensure their safety during the trial.

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ALL

Eligibility criteria

• Inclusion Criteria Groups 1-5:
• • Bacteriologically confirmed rifampicin-susceptible pulmonary TB using phenotypic drug susceptibility testing or a World Health Organization (WHO) approved molecular test.
• • Documentation of HIV status as positive or negative by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit.
• • For individuals with HIV, on locally approved HIV ART for at least 90 days prior to entry.
• • For individuals with HIV, CD4+ cell count ≥250 cells/mm3 obtained within 90 days prior to entry at any network-approved non-US laboratory that is DAIDS IQA certified.
• • For individuals with HIV, HIV-1 RNA below the limit of detection obtained within 90 days prior to entry by any network-approved laboratory outside the US that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
• • Laboratory values within the indicated ranges, obtained within 14 days prior to entry by any network-approved laboratory outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
• • Absolute neutrophil count (ANC) ≥800 cells/mm3
• • Hemoglobin ≥8.5 g/dL for candidates assigned female sex at birth and \>9.0 g/dL for candidates assigned male sex at birth
• • Platelet count ≥100,000/mm3
• • Serum creatinine ≤1.5 X upper limit of normal (ULN)
• • AST (SGOT), ALT (SGPT), and alkaline phosphatase, ≤2.5 X ULN
• • Total bilirubin ≤2 X ULN
• • For candidates who are able to become pregnant, negative serum or urine pregnancy test at or within 7 days prior to entry by any network-approved laboratory or clinic outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
• • Candidates who are able to become pregnant must agree to use an adequate method of contraception (barrier methods or non-hormonal intrauterine device) or abstain from sexual activity that could lead to pregnancy from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.
• • Candidates assigned female sex at birth (AFAB) must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization, from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.
• • For candidates who are not of child-bearing potential, acceptable documentation (written documentation or oral communication from a clinician or clinician's staff documented in source documents: physician report/letter, operative report or other source documentation in the candidate record, discharge summary, laboratory report, etc.) of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, or menopause.
• • Ability and willingness of candidate to provide informed consent.
• Inclusion Criteria Groups 1 and 2 \[Step 2\]:
• • Documented duration of local SOC TB treatment prior to entry into Step 2 (study entry) for i. Group 1 of between 113 and 127 days (i.e., approximately 4 months of TB treatment) ii. Group 2 of between 83 and 97 days (i.e., approximately 3 months of TB treatment)
• Inclusion Criteria, Groups 3, 4, and 5 \[Step 1\]:
• • Initiation of local SOC TB treatment within 7 days prior to entry into Step 1 (Study entry).
• Exclusion Criteria Groups 1-5:
• • Documented M.tb resistance to isoniazid.
• • Breastfeeding.
• • Any previous episode of TB treatment.
• • TB treatment with a local non-standard first-line TB treatment regimen at time of enrollment.
• • Receipt of any investigational drug or any investigational non-TB vaccine since start of TB treatment.
• • Any prior receipt of any investigational TB vaccine.
• • Known allergy or any hypersensitivity to any components of study product or their formulation or any vaccination.
• • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• • History of moderate to serious autoimmune disease requiring immunosuppressive therapy.
• • Receipt of immunosuppressive medications (except as noted below) from start of TB treatment.
• • Corticosteroid nasal spray
• • Inhaled corticosteroids
• • Topical corticosteroids for mild, uncomplicated dermatologic condition
• • A single course of oral/parenteral prednisone or equivalent at doses \<60 mg/day and for \<11 days with completion at least 30 days prior to entry.
• • Receipt of Emergency Use Authorization (EUA)/Emergency Use Listing (EUL) or licensed live attenuated vaccines (e.g., measles, mumps, and rubella \[MMR\], oral polio vaccine \[OPV\], varicella, yellow fever, live attenuated influenza vaccine, live attenuated COVID-19 vaccine) within 30 days prior to entry.
• • Receipt of any EUA/EUL or licensed vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, Hepatitis A or B, not live attenuated COVID-19 vaccine) within 14 days prior to entry.
• • Receipt of immunoglobulin or blood-derived products within 90 days prior to entry.
• • History of angioedema, or anaphylaxis, except as noted.
• • History of generalized urticaria within past 5 years.
• • Malignancy, except as noted.
• • Daily (current) use of a short-acting rescue inhaler (e.g., a beta 2 agonist).
• • Within the previous year, exacerbation of asthma symptoms requiring emergency care, urgent care, hospitalization, or intubation.
• • Uncontrolled diabetes mellitus type 1 or type 2, defined as Hemoglobin A1c (HbA1C) \>7%.
• • Bleeding disorder (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions).
• * Seizure disorder, including either of the following within the previous 3 years:
• • Seizure(s)
• • Use of medications to prevent or treat seizure(s)
• • Acute or serious illness, including COVID-19, requiring systemic treatment and/or hospitalization from start of TB treatment, other than for pulmonary TB.
• • Documentation of clinically significant (as judged by the site investigator) active infections (including HIV-related opportunistic infections) other than TB and HIV requiring treatment within 30 days prior to entry.
• • Evidence of clinically significant disease (as judged by the site investigator) or any other abnormalities (other than the indication being studied) that would interfere with study product, procedures, or interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• • Suspected or documented TB involving the central nervous system, renal TB or TB pericarditis, or current extrapulmonary TB involving other organ systems that might interfere with study product or procedures, as judged by the site investigator.
• • Contraindication to intramuscular injection in both deltoids.