A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV

Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.

Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.

Have any existing condition which may affect IMP injection and/or assessment of local reactions, e.g., tattoos, severe scars, etc.

Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.

Have any current febrile illness (body temperature \>38.0°C/\>100.4°F) or other acute illness within 48 hours prior to IMP administration

Have any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, or any clinically significant cardiac disease per the investigator's judgment.

Have Grade ≥2 hypertension per Food and Drug Administration toxicity grading scale at screening.

Have a known or suspected impairment/alteration of immune function, autoimmune disease, or immunodeficiency (except HIV for PLWH), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, or blood/plasma product within 60 days prior to Visit 1 or planned administration during the study. Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is acceptable.

Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness per protocol is exclusionary regardless of perceived risk of recurrence.

Have received any live vaccines within 28 days prior to Visit 0 or any other vaccines within 14 days prior to Visit 0 or who are planning to receive any vaccine within 28 days of each IMP dose. When possible, standard of care vaccinations should be planned with the study interventions in mind.

For PLWH: Have a history of opportunistic infections and/or AIDS-defining illnesses according to the US Centers for Disease Control and Prevention 2014 and the National Institutes of Health 2024.

For PLWOH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms). For PLWH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms or sputum molecular testing) or current latent tuberculosis infection (by blood interferon-gamma release assay \[IGRA\]). Not excluded: Participants who have a positive IGRA but were fully treated for latent or active tuberculosis infection, per history, review of available records, and per investigator discretion.

For PLWH: Have untreated or incompletely treated syphilis or genital, oropharyngeal or rectal gonorrhea or chlamydia infection.

For PLWH: Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.

Have an estimated glomerular filtration rate of \<45 mL/min/1.73 m2 using the 2021 chronic kidney disease epidemiology creatinine equation.

History of any serious adverse reactions (including anaphylaxis, respiratory distress, angioedema, or urticaria) to vaccines or to vaccine components such as lipids.

Have a history of progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.

Have a history of diabetes mellitus type 1 or type 2, a screening hemoglobin A1c ≥6.5%, or are taking any medication for treatment of diabetes. (Not excluded: A history of isolated gestational diabetes.)

What this study is about