A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Ad… (NCT07698600) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
126 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of at least one adverse event
Timeframe: From dosing through 28 days after each IMP dose
2
Occurrence of at least one serious adverse event
Timeframe: From Dose 1 through the end of study (up to 12 months)
3
Occurrence of at least one adverse event of special interest
Timeframe: From Dose 1 through the end of study (up to 12 months)
4
Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site
Timeframe: Up to 7 days after each IMP dose
5
Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/tiredness, myalgia/muscle pain, fever)