ACE393-103 Vaccination Challenge Study


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

Full Title of Study: “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 Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2009

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.


  • Biological: ACE393
    • ACE393 250 micrograms as intra muscular injection at day 0 and day 21
  • Biological: Placebo vaccine
    • Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Arms, Groups and Cohorts

  • Experimental: 1
    • vaccination with ACE393 followed by challenge with campylobacter jejuni
  • Placebo Comparator: 2
    • Placebo vaccination followed by challenge with campylobacter jejuni

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Moderate or Severe Diarrhea
    • Time Frame: 20 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion criteria (selected):

  • Male or female between 18 and 50 years of age. – General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor. – Negative serum pregnancy test at screening. Exclusion Criteria (selected): – Immunosuppressive illness or clinically significant IgA deficiency. – Positive serology results for HIV, HBsAg, or HCV antibodies. – Evidence of inflammatory arthritis on examination and/or HLA-B27 positive. – Allergy or prior intolerance to selected antibiotics (specified in the protocol) – Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; or passing of loose or liquid stools other than on an occasional basis. – History of diarrhea. – Stool culture positive for Campylobacter, other bacterial enteropathogens and intestinal parasites. – History of microbiologically confirmed Campylobacter infection. – History of vaccination for or ingestion of Campylobacter. – Immunologic evidence of Campylobacter exposure – Serologic evidence of prior Campylobacter infection. – Cell mediated immune response evidence of prior Campylobacter infection. – Fever within 48 hours preceding challenge. – Presence of any signs or symptoms indicative of active infection. – Diarrhea occurring in the 7 days prior to challenge. – Stool culture positive for Campylobacter, other bacterial enteric pathogens or intestinal parasites.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • TD Vaccines A/S
  • Collaborator
    • SNBL Clinical Pharmacology Center, Inc.
  • Provider of Information About this Clinical Study
    • Ingelise Saunders/CEO, ACE BioSciences A/S
  • Overall Official(s)
    • Mohamed Al-Ibrahim, MD, Principal Investigator, Shin Nippon Biomedical Laboratories

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.