Trial studying safety and effects for HIV -1 Infection
Official title A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
ClinicalTrials.gov ID: NCT07698600
What this study is testing
What is BNT168?
BNT168 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv -1 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Are 18 to 50 years of age inclusive at the time of giving informed consent.
- For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.
- Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Are overall healthy as defined in the protocol.
- Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol.
You likely can't join if
- Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or...
- 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...
- 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...
See the full eligibility criteria
Who can join
- Are 18 to 50 years of age inclusive at the time of giving informed consent.
- For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.
- Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Are overall healthy as defined in the protocol.
- Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol.
- For PLWOH, starting at Visit 0 and continuously until the last planned visit in this study, individuals who:
- Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
- Agree to discuss HIV disease risks.
- Agree to HIV infection risk reduction counseling.
- For PLWH, individuals who:
- Have been on stable continuous cART for at least 12 months (defined as no interruptions longer than 14 continuous days) and with no changes in the components of the cART for at least 12 weeks prior to Visit 1.
- Are not on a non-nucleoside reverse transcriptase inhibitor at screening.
- Have never received lenacapavir and have not received other long-acting antiretroviral therapies in the last 2 years (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
- Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.
- Have a CD4+ T cell count of ≥500 cells/µL at Visit 0.
- Per medical history, any available prior CD4+ T cell count must be ≥350 cells/µL.
- Have plasma HIV-1 RNA levels of \<50 cps/mL for ≥6 months prior to study entry per investigator review of records and/or participant history (single measurements of \<200 cps/mL are allowed if preceded and followed by...
- Are willing to stop cART and undergo ATI at the timepoint defined in the protocol.
- Are willing to re-initiate cART upon meeting cART restart criteria.
- Site investigator anticipates that a fully active alternative cART regimen could be constructed and would be available in the event of virologic failure on the participant's current cART regimen.
- Agree not to donate blood from the time of first IMP administration until 90 days after the last IMP administration for PLWOH and until the End of Study Visit for PLWH. Key
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.) NOTE: Other...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.