Oral Vaccination Against Clostridium Difficile Infection (CDVAX)

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

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

Study Overview

• Status: Terminated
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Biological: CDVAX

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDVAX	Biological: CDVAX

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Simon M. Cutting

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 14, 2017
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Clostridium Infections
• Other Study ID Numbers: CDVAX