Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
H4:IC31 · 1 trial · 1 indication
The number of solicited and unsolicited adverse events (AEs), including serious adverse events (SAEs), recorded post-vaccination for all participants.
Flow cytometry was used to examine TB Mb-specific CD4+ and CD8+ T-cell responses using the ICS assay. The antigens used to stimulate cells in this assay included peptide pools for the vaccine-matched proteins (Ag85B, ESAT-6, Rv2660c, and TB 10.4) as well as complex TB antigens (TB whole cell lysate \[TB WCL\], and BCG Pasteur strain.
| Arm | Type | Description |
|---|---|---|
| Group 1 H4:IC31 | EXPERIMENTAL | 15 mcg H4/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56. |
| Group 2 H56:IC31 | EXPERIMENTAL | 5 mcg H56/500 nmol IC31 administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56. |
| Group 3 BCG (2-8 x 105 CFU) | ACTIVE_COMPARATOR | Administered IM as 0.1 mL in either deltoid muscle at Day 0. |
| Group 4 Control Sodium Chloride 0.9% | PLACEBO_COMPARATOR | Administered IM as 0.5 mL in alternating deltoid muscle at Days 0 and 56. |
| Name | Type | Description |
|---|---|---|
| H4:IC31 | BIOLOGICAL | H4 contains Mtb antigens Ag85B and TB10.4 |
| H56:IC31 | BIOLOGICAL | H56 contains Mtb antigens ESAT-6, and Rv2660c |
| BCG | BIOLOGICAL | - |
| Control Sodium Chloride 0.9% | BIOLOGICAL | - |
Inclusion Criteria: 1. Age of 12 to ≤ 17 years at enrollment 2. Minimum weight ≥ 40 kg 3. Previous BCG vaccination at least 5 years ago documented by scarification or medical card 4. No evidence of active TB disease, as determined by history, physical examination and, if deemed appropriate, sputum ...
| 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 |
H4:IC31 is an investigational vaccine being studied for the prevention of tuberculosis. It is currently in Phase 1 clinical development and has been evaluated in a completed trial involving healthy adolescents in South Africa. The vaccine is being developed by Sanofi.
H4:IC31 is a monoclonal antibody designed to target tuberculosis. It is intended to stimulate an immune response against the bacteria that cause tuberculosis, potentially providing protection against the disease. The vaccine is being studied for its safety and immunogenicity in healthy adolescents.
H4:IC31 is being developed by Sanofi, a global biopharmaceutical company. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for the prevention of tuberculosis. The company is listed on the stock exchange under the ticker symbol SNY.
H4:IC31 is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and immunogenicity in healthy adolescents.
H4:IC31 has been studied in one clinical trial with the identifier NCT02378207. This was a Phase 1, randomized, double-blind, placebo-controlled study that evaluated the safety and immunogenicity of BCG, H4:IC31, and H56:IC31 revaccination in healthy adolescents. The trial was completed in South Africa and enrolled 84 participants.