Oral Vaccination Against Clostridium Difficile Infection

NCT02991417 | Terminated Phase 1

• 1 other identifier: CDVAX
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of specific mucosal and systemic immunity

  First treatment up to end of treatment + 14 days (56 days after starting study drug)

Study Arms (1)

CDVAX

EXPERIMENTAL

Biological: CDVAX

Interventions

CDVAX BIOLOGICAL

CDVAX

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon M. Cutting: lead

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 13, 2016
• Study Start: January 1, 2017
• Primary Completion: March 14, 2017
• Study Completion: June 8, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07