Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AERAS-402 · 1 trial · 1 indication
To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Two doses of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection) |
| Group B | EXPERIMENTAL | One dose of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection) |
| Group C | EXPERIMENTAL | Three doses of AERAS-402 (1x10\^11 vp intramuscular injection) |
| Name | Type | Description |
|---|---|---|
| AERAS-402 | BIOLOGICAL | Intramuscular needle injection 1x10\^11 vp |
| MVA85A | BIOLOGICAL | Intradermal needle injection 1x10\^8 pfu |
Inclusion Criteria: Subjects must meet all of the following criteria to enter the trial: * Healthy adult aged 18-55 years * Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF; and able to travel to Oxford for vaccinations) for the duration of the trial period * No relevant findings in...
| 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 |
AERAS-402 is an investigational therapy being studied for tuberculosis, an infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in clinical trials to assess its safety and potential efficacy in preventing or treating tuberculosis.
AERAS-402 is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical research on this investigational therapy for tuberculosis.
AERAS-402 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is still undergoing early-stage clinical trials to evaluate its safety and tolerability in humans.
AERAS-402 has been studied in one completed Phase 1 clinical trial with the identifier NCT01683773. This trial, titled 'Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A,' enrolled 40 participants in the United Kingdom and evaluated the safety of the drug in healthy volunteers aged 18 years and older.
AERAS-402 is being studied as a potential vaccine for tuberculosis. The completed clinical trial NCT01683773 was described as a safety study of tuberculosis vaccines, indicating that AERAS-402 is being developed as a vaccine candidate. However, it remains investigational and is not yet approved for use.