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Oral Vaccination Against Clostridium Difficile Infection (CDVAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991417
Recruitment Status : Terminated
First Posted : December 13, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Simon M. Cutting, Royal Holloway University

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

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: CDVAX Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : June 8, 2017

Arm Intervention/treatment
Experimental: CDVAX Biological: CDVAX



Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: First treatment up to end of treatment + 28 days (70 days after treatment start) ]
    Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination


Secondary Outcome Measures :
  1. Evaluation of specific mucosal and systemic immunity [ Time Frame: First treatment up to end of treatment + 14 days (56 days after starting study drug) ]
    Measured by specific secretory IgA, serum IgA and serum IgG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Simon M. Cutting, Professor, Royal Holloway University
ClinicalTrials.gov Identifier: NCT02991417    
Other Study ID Numbers: CDVAX
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Infection
Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases