Oral Vaccination Against Clostridium Difficile Infection

NCT ID: NCT02991417

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-08

Brief Summary

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

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CDVAX

Group Type: EXPERIMENTAL

CDVAX

Intervention Type: BIOLOGICAL

Interventions

CDVAX

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Male

3. Age: 18-50 years (limits included)

4. Body mass index within 18.5 and 29.9 kg/m²

5. Ability to read and comprehend study information

6. Non-smokers or light smokers (<4 cigarettes per day)

7. In good physical and mental health as determined by the following:

1. Complete medical history

2. Complete physical and neurological examination

3. Vital signs including blood pressure, heart rate, respiratory rate, and temperature

4. Standard 12-lead ECG

5. 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.

6. Vital signs, clinical laboratory measurements, and ECG measurements may be repeated at the discretion of the investigator

Exclusion Criteria

1. Evidence of C. difficile infection

2. Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure

3. Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea

4. History of malignancy within 5 years

5. History of anaphylaxis, asthma or severe vaccine or allergic drug reaction

6. Known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease

7. Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days

8. Vaccination within the previous 30 days (except for influenza vaccination)

9. Blood or organ donation within the previous 60 days

10. Evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator)

11. 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

12. History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse

13. Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV)-1/2 antibodies

14. Participation in any other investigational drug or device study within 60 days prior to the first study drug administration

15. Relatives of, or staff directly reporting to the principal investigator

16. Vulnerable subjects

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Simon M. Cutting

OTHER

Sponsor Role: lead

Responsible Party

Simon M. Cutting

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

CDVAX

Identifier Type: -

Identifier Source: org_study_id