Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05592223 | Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines | PHASE1 | COMPLETED | 20 | — | — | Dec 6, 2022 | Dec 1, 2023 | Dec 16, 2025 | 1 | United States |
Through microbial culture, quantify in colony forming units (CFU) BCG bacterial burden in skin biopsies from challenge sites. Outcome measure if the mean cfu from day 15 biopsy specimens.
| Arm | Type | Description |
|---|---|---|
| BCG Challenged-Isoniazid Treated | ACTIVE_COMPARATOR | Will receive INH in the dose of 300 mg for three days post BCG injection. |
| BCG Challenged-Isoniazid Untreated | PLACEBO_COMPARATOR | Will not receive any INH or RIF dose. |
| BCG Challenged-RIF Treated | ACTIVE_COMPARATOR | Will receive RIF in the dose of 600 mg for seven days post BCG injection. |
| Name | Type | Description |
|---|---|---|
| BCG Vaccine USP | DRUG | 2x10\^6 cfu Tice® BCG (ID) |
| Isoniazid | DRUG | INH in the dose of 300 mg for three days post BCG injection. |
| Rifampin | DRUG | RIF in the dose of 600 mg for seven days post BCG injection. |
Inclusion Criteria: * Provide written informed consent prior to initiation of any study procedures, * Are males or non-pregnant females between the ages of 18 and 45 years, inclusive, * Women of childbearing potential in sexual relationships with men must use an acceptable method of preventing conc...
| 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 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |