ACE393-103 Vaccination Challenge Study

Phase 2

• Conditions: Campylobacter Infection
• Interventions: Biological: ACE393; Biological: Placebo vaccine

• Registration Number: NCT00859716
• Lead Sponsor: TD Vaccines A/S

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-10
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Last Update Submitted: 2009-03-10
• Study First Posted: 2009-03-11
• Last Update Posted: 2009-03-11
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ACE393	vaccination with ACE393 followed by challenge with campylobacter jejuni
2	Placebo vaccine	Placebo vaccination followed by challenge with campylobacter jejuni

Primary Outcome Measures

Name	Time	Method
Incidence of Moderate or Severe Diarrhea	20 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shin Nippon Biomedical Laboratories; 🇺🇸 Baltimore, Maryland, United States