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Mtb72F/AS02 · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Mtb72F/AS02A | BIOLOGICAL | - |
| Mtb72F/AS02. | BIOLOGICAL | - |
INCLUSION CRITERIA * Written informed consent * Healthy PPD-positive volunteers aged 18 to 50 years * No active pulmonary disease as confirmed by chest X-ray * No history of extrapulmonary TB * Seronegative for HIV 1 and 2, HBsAg, and HCV * Clinically normal laboratory values for creatinine, alanin...
| 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 |
Mtb72F/AS02 is an investigational vaccine candidate being developed for the prevention of tuberculosis (TB). It is currently in clinical development and has not been approved by regulatory authorities. The vaccine is designed to be administered to healthy adults, as studies have enrolled healthy volunteers to assess its safety and immunogenicity.
Mtb72F/AS02 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical trials to evaluate the safety and immunogenicity of this tuberculosis vaccine candidate in healthy adult populations.
Mtb72F/AS02 is in Phase 2 clinical development. It has completed two clinical trials, one Phase 2 study and one Phase 1 study, both of which have been completed. The vaccine remains investigational and is not yet approved for use outside of clinical research settings.
Mtb72F/AS02 has been evaluated in two completed clinical trials. NCT00146744 was a Phase 2 study in healthy PPD-positive adults in Switzerland, enrolling 38 participants. NCT00291889 was a Phase 1 study in healthy PPD-negative adults in Belgium, enrolling 50 participants. Both trials assessed safety and immunogenicity.
Mtb72F/AS02 is a vaccine candidate that combines the Mtb72F antigen with the AS02 adjuvant system. The antigen is designed to stimulate an immune response against Mycobacterium tuberculosis, the bacterium that causes tuberculosis. The AS02 adjuvant is intended to enhance the body's immune response to the antigen.