Tuberculosis
Conditions
Sponsors
BioNTech SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria (applicable to Part A and Part B unless otherwise specified): 1. Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures. 2. Are 18 to 55 years of age inclusive (in Part A) or 18 years of age or older (in Part B) and have a body mass index over 18.5 kg/m^2 and under 35 kg/m^2 and weigh at least 50 kg. 3. Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the study. This includes that they are able to understand and follow study-related instructions. 4. In Part A only: Have a reported history or evidence of (scar) of Bacillus Calmette-Guérin (BCG) vaccination. 5. Are overall healthy in the clinical judgment of the investigator based on the medical history and clinical assessment (including physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram [ECG]). In Part B only for PLWH: 5.1.Have documented HIV infection fulfilling all of the following criteria: 5.1.1. Have anti-HIV antibodies at screening. 5.1.2. Have been on antiretroviral therapy for at least three consecutive months at screening. 5.1.3. Have documented HIV RNA <200 copies/mL at screening. 5.1.4. Have cluster of differentiation 4 (CD4)+ T-cell counts =200 cells/µL at screening. 5.1.5. Have had tuberculosis (TB) preventive treatment (TPT) in the past, per participant report, and are not receiving TPT at the time of screening (and are not diagnosed with TB at screening), according to the judgment of the investigators. Hemoglobin =12.0 g/dL (in Part A) and =11.0 g/dL (in Part B) for volunteers who were born female, =13.0 g/dL (in Part A) and =12.5 g/dL (in Part B) for volunteers who were born male. More inclusion criteria refer to the study protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (applicable to Part A and Part B unless otherwise specified): Any existing condition which may affect vaccine injection and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. Any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. In Part A only: Baseline clinical screening questionnaire positive for pulmonary TB disease or history of sputum sample positive for TB, or history of treatment for active or latent TB. In Part B only: For HIV-negative subjects: Baseline clinical screening questionnaire positive for pulmonary TB disease or history of sputum sample positive for TB, or history of treatment for TB infection or disease. For PLWH: Baseline clinical screening questionnaire positive for pulmonary TB disease or history of sputum sample positive for TB, or current receipt of TB preventive treatment or treatment for TB disease. Current febrile illness (body temperature =38.0°C) or other acute illness at Visit 0. More exclusion criteria refer to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each dose ;Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle pain & joint pain, chills, and fever) up to 7 days after each dose;Proportion of participants with at least one adverse event (AE) occurring from each dose to 28 days after each dose;Proportion of participants with at least one unsolicited AE occurring from Dose 1 to 28 days post-Dose 3;Proportion of participants with at least one serious AE or AE of special interest occurring from Dose 1 up to 168 days post-Dose 3;Number of unsolicited AEs from Dose 1 to 28 days post-Dose 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Objective - To describe the CMI response induced by BNT164 vaccines (BNT164a1 and/or BNT164b1) per different dose levels in HIV-negative subjects or PLWH;To describe the humoral responses induced by BNT164 vaccines (BNT164a1 and/or BNT164b1) per different dose levels in HIV-negative subjects or PLWH | — |
Countries
Mozambique
Contacts
Public ContactBioNTech clinical trials patient information BioNTech clinical trials patient information
BioNTech clinical trials patient information
Outcome results
None listed