Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AERAS-404 · 1 trial · 1 indication
Includes injection site AEs and systemic AEs.
| Arm | Type | Description |
|---|---|---|
| BCG SSI prime with Placebo | PLACEBO_COMPARATOR | All subjects received BCG Vaccine SSI, 2-8 x 10\^5 CFU (BCG) on Study Day -42. Placebo containing 0,8 mL sterile buffer consisting of 10 mmol Tris and 169 mmol NaCl aqueous solution was administered on Study Days 0, 56, and 231. |
| BCG SSI prime with Placebo and AERAS-404 | EXPERIMENTAL | All subjects received BCG Vaccine SSI, 2-8 x 10\^5 CFU (BCG) on Study Day -42. Placebo on Study Day 0 followed by AERAS-404 50/500 on Study Days 56 and 231. AERAS-404 50/500 was a fixed dose combination of H4 50 mcg and IC31 500 nmol (KLK equivalent). H4 and IC31 adjuvant were supplied as separate single-dose vials containing frozen product as follows: * H4 antigen: 500 mcg/mL (100 mcg/0.2 mL), in 10 mmol/L Tris-HCl, pH 8.3. * IC31 adjuvant: 1250 nmol/mL (1000 nmol/0.8 mL) KLK equivalent, in 10 mmol/L Tris-HCl and 169 mmol/L NaCl. |
| BCG SSI prime with AERAS-404 | EXPERIMENTAL | All subjects received BCG Vaccine SSI, 2-8 x 10\^5 CFU (BCG) on Study Day -42. AERAS-404 50/500 on Study Days 0, 56, and 231. AERAS-404 50/500 was a fixed dose combination of H4 50 mcg and IC31 500 nmol (KLK equivalent). H4 and IC31 adjuvant were supplied as separate single-dose vials containing frozen product as follows: * H4 antigen: 500 mcg/mL (100 mcg/0.2 mL), in 10 mmol/L Tris-HCl, pH 8.3. * IC31 adjuvant: 1250 nmol/mL (1000 nmol/0.8 mL) KLK equivalent, in 10 mmol/L Tris-HCl and 169 mmol/L NaCl. |
| Name | Type | Description |
|---|---|---|
| BCG SSI | BIOLOGICAL | The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area. |
| Placebo | BIOLOGICAL | This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection. |
| AERAS-404 | BIOLOGICAL | AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection. |
Inclusion Criteria: 1. Had completed the written informed consent process. 2. Was male or female. 3. Was age ≥ 18 years and ≤ 50 years. 4. Agreed to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and had no current plans to move ...
| 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 |