Clostridium Difficile Diarrhea, Clostridium Difficile Infection
Conditions
Keywords
Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine
Brief summary
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
Detailed description
This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).
Interventions
BIOLOGICALVaccine diluent buffer
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
BIOLOGICALClostridium difficile toxoid vaccine (50 μg)
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
BIOLOGICALClostridium difficile toxoid vaccine (100 μg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult males or females, 18 - 55 years in good general health
Exclusion criteria
* Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening * Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication * Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Day 0 up to 70 days post first vaccination |
Participant flow
Recruitment details
Participants were enrolled on 28 March 2006 in 2 clinical centers in the US.
Pre-assignment details
A total of 36 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vaccine Group Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. | 12 |
| Clostridium Difficile Toxoid Vaccine Group 1 Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. | 12 |
| Clostridium Difficile Toxoid Vaccine Group 2 Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo Vaccine Group | Clostridium Difficile Toxoid Vaccine Group 1 | Clostridium Difficile Toxoid Vaccine Group 2 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 12 Participants | 12 Participants | 12 Participants |
| Age Continuous | 35.1 Years STANDARD_DEVIATION 11.84 | 38.3 Years STANDARD_DEVIATION 12.98 | 36.9 Years STANDARD_DEVIATION 12.67 | 30.0 Years STANDARD_DEVIATION 8.57 |
| Region of Enrollment United States | 36 participants | 12 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 23 Participants | 7 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Time frame: Day 0 up to 70 days post first vaccination
Population: Safety assessments were on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood urea increased | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cells urine positive | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Myalgia | 1 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood potassium decreased | 1 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Eosinophil count increased | 3 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Sinus congestion | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Headache | 5 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Abdominal pain | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Malaise | 0 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Protein urine present | 1 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site erythema | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Red blood cells urine positive | 2 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Fatigue | 3 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Urine ketone body present | 0 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site swelling | 0 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Diarrhoea | 3 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site pain | 7 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site warmth | 0 Participants |
| Placebo Vaccine Group | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cell count increased | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site warmth | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Malaise | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cell count increased | 4 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood urea increased | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site pain | 12 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Myalgia | 5 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site erythema | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Diarrhoea | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Sinus congestion | 0 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Urine ketone body present | 0 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Fatigue | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cells urine positive | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood potassium decreased | 4 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Eosinophil count increased | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Abdominal pain | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Red blood cells urine positive | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Protein urine present | 4 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site swelling | 4 Participants |
| Clostridium Difficile Toxoid Vaccine Group 1 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Headache | 4 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Urine ketone body present | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site pain | 9 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Headache | 5 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood potassium decreased | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Protein urine present | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cell count increased | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Diarrhoea | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | White blood cells urine positive | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Eosinophil count increased | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Abdominal pain | 3 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Red blood cells urine positive | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site swelling | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site warmth | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Malaise | 0 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Fatigue | 2 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Myalgia | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Injection site erythema | 1 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Blood urea increased | 0 Participants |
| Clostridium Difficile Toxoid Vaccine Group 2 | Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. | Sinus congestion | 1 Participants |