Clinical Trial: ACE393-103 Vaccination Challenge Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo Controlled Vaccination-Challenge Study of ACE393 to Determine Efficacy Against the Symptoms of Moderate to Severe Campylobacter Jejuni Infection in Normal Healthy V

Brief Summary: The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.

Detailed Summary: This study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior C.jejuni infections or immunity, will be vaccinated with ACE393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with C.jejuni. The study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ACE393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with C.jejuni. During the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). Criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. All volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). Discharge criteria are predefined. Post-discharge follow-up will further monitor safety, confirm C .jejuni eradication after antibiotic therapy, and assess immunologic response.
Sponsor: TD Vaccines A/S

Current Primary Outcome: Incidence of Moderate or Severe Diarrhea [ Time Frame: 20 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 Weeks ]
  • Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 weeks ]
  • Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 weeks ]
  • Incidence of severe diarrhea [ Time Frame: 20 weeks ]


Original Secondary Outcome: Same as current

Information By: TD Vaccines A/S

Dates:
Date Received: March 10, 2009
Date Started: October 2008
Date Completion: July 2009
Last Updated: March 10, 2009
Last Verified: March 2009