TerminatedPhase 1

Oral Vaccination Against Clostridium Difficile Infection

3 participantsStarted 2017-01

Plain-language summary

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

Age range18 Years – 50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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)

Incidence and severity of adverse events

Timeframe: First treatment up to end of treatment + 28 days (70 days after treatment start)

NCT IDNCT02991417

SponsorSimon M. Cutting

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03-14