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Also known as ACAM-CDIFF™
Clostridium difficile Toxoid Vaccine · 2 trials · 2 indications
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
| Arm | Type | Description |
|---|---|---|
| Placebo Vaccine | PLACEBO_COMPARATOR | 0.9% Normal saline |
| Low dose | EXPERIMENTAL | Low dose vaccine with adjuvant |
| High dose 1 | EXPERIMENTAL | High-dose vaccine with adjuvant |
| High dose 2 | EXPERIMENTAL | High-dose vaccine without adjuvant |
| Vaccine Group | EXPERIMENTAL | Participants will receive the candidate C. difficile toxoid vaccine |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| 0.9% Normal Saline | BIOLOGICAL | 0.5 mL, intramuscular on Days 0, 7, and 28 |
| Clostridium difficile toxoid vaccine | BIOLOGICAL | 0.5 mL, intramuscular on Days 0, 7, and 28 |
| Clostridium difficile toxoid vaccine with adjuvant | BIOLOGICAL | 0.5 mL, intramuscular on Days 0, 7, and 28 |
Inclusion Criteria: 1. Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study. 2. Subjects who are experiencing a first event of CDI diagnosed within the last 10 days. 3. Subjects who are medically stable. 4...
Clostridium difficile Toxoid Vaccine is an investigational vaccine being developed to prevent Clostridium difficile infection and the diarrhea it causes. It is designed to prompt the immune system to recognize the toxins produced by the bacterium. Sanofi is developing the vaccine, which has been studied in both healthy adult volunteers and in patients with Clostridium difficile infection.
Clostridium difficile Toxoid Vaccine is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi conducted the clinical studies of this candidate vaccine, including a Phase 1 trial in Japan and a Phase 2 trial in the United States and United Kingdom.
Clostridium difficile Toxoid Vaccine is in Phase 1 development. It is an investigational vaccine and has not been approved by the FDA. A Phase 1 study in healthy Japanese adults aged 40 to 75 has been completed, and a Phase 2 study in patients with Clostridium difficile infection has also been completed.
Clostridium difficile Toxoid Vaccine has been studied in two completed clinical trials. NCT01896830 was a Phase 1 trial in healthy adult subjects aged 40 to 75 years in Japan, enrolling 102 participants. NCT00772343 was a Phase 2 trial in subjects with Clostridium difficile infection in the United States and United Kingdom, enrolling 116 participants.
Yes, ACAM-CDIFF is an alternative name for Clostridium difficile Toxoid Vaccine. The Phase 2 trial NCT00772343 referred to the candidate as ACAM-CDIFF. Both names refer to the same Sanofi vaccine candidate being studied for the prevention of Clostridium difficile infection and associated diarrhea.