Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT164a1 · 2 trials · 1 indication
Part A and Part B
Part A and Part B
Part A and Part B
Part A and Part B
Part A and Part B. In Part A, from Dose 1 up to 168 days post-Dose 3. In Part B, from Dose 1 up to 28 days post- Dose 3.
Part A and Part B
| Arm | Type | Description |
|---|---|---|
| Part A: BNT164a1 | EXPERIMENTAL | Escalating dose levels |
| Part A: BNT164b1 | EXPERIMENTAL | Escalating dose levels |
| Part B: BNT164a1 Dose level (DL) 1 | EXPERIMENTAL | - |
| Part B: BNT164a1 DL 2 | EXPERIMENTAL | - |
| Part B: BNT164b1 DL 1 | EXPERIMENTAL | - |
| Part B: BNT164b1 DL 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Isotonic sodium chloride (NaCl) solution (0.9%) |
| BNT164a1 | EXPERIMENTAL | Escalating dose levels |
| BNT164b1 | EXPERIMENTAL | Escalating dose levels |
| Name | Type | Description |
|---|---|---|
| BNT164a1 | BIOLOGICAL | Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection |
| BNT164b1 | BIOLOGICAL | Multi-antigen RNA vaccine for active immunization against tuberculosis administered as intramuscular injection |
| Placebo | OTHER | Placebo |
Inclusion Criteria (applicable to Part A and Part B unless otherwise specified): * Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures. * Are 18 to 55 years of age inclusive (in Part A) or 18 years of age or older (in Part B)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
BNT164a1 is an investigational RNA-based vaccine being developed for the prevention of tuberculosis. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to generate immune responses against tuberculosis in healthy volunteers, including those previously vaccinated with BCG.
BNT164a1 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 immunogenicity of this investigational RNA-based tuberculosis vaccine in healthy adult volunteers.
BNT164a1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been initiated, with one completed and one active but not recruiting participants.
BNT164a1 has been evaluated in two Phase 1 clinical trials. NCT05537038, completed in Germany, enrolled 120 healthy volunteers to assess safety and immune responses. NCT05547464, active but not recruiting in Mozambique and South Africa, enrolled 497 BCG-vaccinated volunteers. Both trials are randomized, double-blind, and placebo-controlled.
BNT164a1 is an RNA-based vaccine that works by delivering genetic instructions to cells to produce antigens that mimic parts of the tuberculosis bacterium. This stimulates the immune system to recognize and respond to the pathogen. The vaccine is designed to elicit protective immune responses without causing the disease itself.
BNT164a1 is one of two investigational RNA-based tuberculosis vaccines being studied by BioNTech. The clinical trials NCT05537038 and NCT05547464 evaluate both BNT164a1 and BNT164b1 in the same studies. They are distinct vaccine candidates but are being tested in parallel for safety and immunogenicity.