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Clostridium difficile toxoids A and B · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively. |
| Group 2 | EXPERIMENTAL | Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively. |
| Group 3 | EXPERIMENTAL | Participants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively. |
| Group 4 | EXPERIMENTAL | Participants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively. |
| Group 5 | PLACEBO_COMPARATOR | Participants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively. |
| Group 6 | EXPERIMENTAL | Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively. |
| Group 7 | EXPERIMENTAL | Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively. |
| Name | Type | Description |
|---|---|---|
| Clostridium difficile toxoids A and B (Low-dose with adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Days 0, 7, and 30 |
| Clostridium difficile toxoids A and B (Low-dose without adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Days 0, 7, and 30 |
| Clostridium difficile toxoids A and B (high-dose with adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Days 0, 7, and 30 |
| Clostridium difficile toxoids A and B (high-dose without adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Days 0, 7, and 30 |
| Placebo: 0.9% normal saline | BIOLOGICAL | 0.5 mL, Intramuscular on Days 0, 7, and 30 |
Inclusion Criteria: * Aged 40 to 75 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or abstinence from a...
Clostridium difficile toxoids A and B is an investigational vaccine being developed by Sanofi (ticker SNY) for the prevention of Clostridium difficile infection. It is designed to stimulate an immune response against the toxins produced by the bacterium. The vaccine is in Phase 2 clinical development and has not been approved by the FDA.
Clostridium difficile toxoids A and B is being studied for the prevention of Clostridium difficile infection, a condition that can cause diarrhea and severe intestinal complications. It is intended for adults, with clinical trials enrolling participants aged 40 years and older. The vaccine is not yet approved for any indication.
Clostridium difficile toxoids A and B targets collagen proteins including COL1A2, COL1A1, COL2A1, COL3A1, COL4A1, and COL5A1. These targets belong to the hydrolytic enzyme class. The vaccine aims to elicit an immune response against these components, though the exact mechanism in Clostridium difficile infection is not fully established.
Clostridium difficile toxoids A and B is being developed by Sanofi, which trades under the ticker symbol SNY. Sanofi is a global pharmaceutical company. The vaccine is part of Sanofi's infectious disease pipeline.
Clostridium difficile toxoids A and B is in Phase 2 clinical development. It has not been approved by the FDA and remains investigational. A Phase 2 trial has been completed, but no active trials are currently listed.
Clostridium difficile toxoids A and B has been studied in a completed Phase 2 trial, NCT01230957, titled "Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults." The trial enrolled 650 participants in the United States and evaluated the vaccine in adults aged 40 years and older.