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Clinical Trials/NCT02991417
NCT02991417TerminatedPhase 1

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

Simon M. Cutting0 sites3 target enrollmentStarted: January 1, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Terminated
Sponsor
Enrollment
3
Primary Endpoint
Incidence and severity of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Written informed consent
  • •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

Arms & Interventions

CDVAX

Experimental

Intervention: CDVAX (Biological)

Outcomes

Primary Outcomes

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 Outcomes

  • Evaluation of specific mucosal and systemic immunity(First treatment up to end of treatment + 14 days (56 days after starting study drug))

Investigators

Sponsor
Simon M. Cutting
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Simon M. Cutting

Professor

Royal Holloway University

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