The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
ACE393 250 micrograms as intra muscular injection at day 0 and day 21
Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
Shin Nippon Biomedical Laboratories
Baltimore, Maryland, United States
Incidence of Moderate or Severe Diarrhea
Time frame: 20 weeks
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
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