Oral Vaccination Against Clostridium Difficile Infection

Study Overview
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Brief Summary
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This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.

Official Title
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Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Biological: CDVAX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Male Age: 18-50 years (limits included) Body mass index within 18.5 and 29.9 kg/m² Ability to read and comprehend study information Non-smokers or light smokers (<4 cigarettes per day) In good physical and mental health as determined by the following: Complete medical history Complete physical and neurological examination Vital signs including blood pressure, heart rate, respiratory rate, and temperature Standard 12-lead ECG Clinical laboratory (biochemistry, haematology and urinalysis) tests. Blood and urine samples may be drawn up to 3 weeks prior to the baseline visit of the study provided all data are available and evaluated prior to administration of study drug. Values of laboratory results outside normal reference ranges may be acceptable if the investigator considers that they do not compromise the safety of the subjects or the conduct of the study. Vital signs, clinical laboratory measurements, and ECG measurements may be repeated at the discretion of the investigator Exclusion Criteria: Evidence of C. difficile infection Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea History of malignancy within 5 years History of anaphylaxis, asthma or severe vaccine or allergic drug reaction Known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days Vaccination within the previous 30 days (except for influenza vaccination) Blood or organ donation within the previous 60 days Evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator) Use of prescription medication or regular use of over-the-counter medicines or herbal or dietary supplements. Acetaminophen/paracetamol may be used intermittently as needed for pain History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV)-1/2 antibodies Participation in any other investigational drug or device study within 60 days prior to the first study drug administration Relatives of, or staff directly reporting to the principal investigator Vulnerable subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDVAX<br> | Biological: CDVAX<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events | Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination | First treatment up to end of treatment + 28 days (70 days after treatment start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of specific mucosal and systemic immunity | Measured by specific secretory IgA, serum IgA and serum IgG | First treatment up to end of treatment + 14 days (56 days after starting study drug) |