Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT168 · 1 trial · 1 indication
In PLWOH and PLWH. By cohort and pooled placebo.
In PLWOH and PLWH. By cohort and pooled placebo.
In PLWOH and PLWH. By cohort and pooled placebo.
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
| Arm | Type | Description |
|---|---|---|
| A1 in PLWOH - BNT168 dose level 1 | EXPERIMENTAL | - |
| A2 in PLWOH - BNT168 dose level 2 | EXPERIMENTAL | - |
| A3 in PLWOH - BNT168 dose level 3 | EXPERIMENTAL | - |
| A4 in PLWH - BNT168 dose level 2 | EXPERIMENTAL | This cohort will undergo ATI post vaccination |
| A5 in PLWH - BNT168 dose level 3 | EXPERIMENTAL | This cohort will undergo ATI post vaccination |
| PLWOH - Placebo | PLACEBO_COMPARATOR | - |
| PLWH - Placebo | PLACEBO_COMPARATOR | PLWH participants receiving placebo will also undergo ATI post vaccination |
| Name | Type | Description |
|---|---|---|
| BNT168 | BIOLOGICAL | Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections |
| Placebo | OTHER | Isotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections |
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 broad...
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BNT168 is an investigational RNA-based vaccine being developed by BioNTech SE for HIV-1 infection. It is currently in Phase 1 clinical development and is designed to be evaluated for safety and immune responses in adults living with or without HIV. It has not been approved by the FDA.
BNT168 is being studied for HIV-1 infection as a preventive or immunotherapeutic RNA-based vaccine candidate. The Phase 1 trial evaluates its safety and immune responses in adults living with or without HIV. It is investigational and has not been approved for any indication.
BNT168 is developed by BioNTech SE, which trades on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the Phase 1 clinical trial evaluating the candidate in adults living with or without HIV.
BNT168 is in Phase 1 clinical development. It is an investigational RNA-based vaccine candidate for HIV-1 infection and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants.
BNT168 is being evaluated in one Phase 1 clinical trial, NCT07698600, titled a clinical trial to look at the safety and immune responses of the RNA-based vaccine BNT168 in adults living with or without HIV. The trial is recruiting 126 participants across the United States and South Africa.
Yes, the Phase 1 trial of BNT168, NCT07698600, is randomized, double-blind, and placebo-controlled. It is enrolling 126 adults aged 18 years and older, including healthy volunteers, in the United States and South Africa to assess safety and immune responses.