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 studied for the prevention or treatment of HIV-1 infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BNT168 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and immune responses of this vaccine candidate.
BNT168 is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to assess its safety and immunogenicity.
BNT168 is being evaluated in a Phase 1 clinical trial registered as NCT07698600. This randomized, double-blind, placebo-controlled study is recruiting 126 adults living with or without HIV in the United States to assess the safety and immune responses of the vaccine.
BNT168 is an RNA-based vaccine designed to induce immune responses against HIV-1. It is being studied in adults with or without HIV to evaluate its ability to generate protective immunity, though the specific antigen or mechanism has not been disclosed in available information.