Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)

Conditions
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Clostridium Difficile Infection, Clostridium Difficile Diarrhea

Intervention / Treatment
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* Biological: Vaccine diluent buffer
* Biological: Clostridium difficile toxoid vaccine (50 μg)
* Biological: Clostridium difficile toxoid vaccine (100 μg)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo vaccine group<br>Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively. | Biological: Vaccine diluent buffer<br>* 0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.<br>|
| Experimental: Clostridium Difficile Vaccine Group 1<br>Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. | Biological: Clostridium difficile toxoid vaccine (50 μg)<br>* 0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.<br>|
| Experimental: Clostridium Difficile Vaccine Group 2<br>Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. | Biological: Clostridium difficile toxoid vaccine (100 μg)<br>* 0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine