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ACE393-103 Vaccination Challenge Study (ACE393-103VC)

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ClinicalTrials.gov Identifier: NCT00859716
Recruitment Status : Unknown
Verified March 2009 by TD Vaccines A/S.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2009
Last Update Posted : March 11, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Campylobacter Infection Biological: ACE393 Biological: Placebo vaccine Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Volunteers
Study Start Date : October 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
vaccination with ACE393 followed by challenge with campylobacter jejuni
Biological: ACE393
ACE393 250 micrograms as intra muscular injection at day 0 and day 21
Other Name: Campylobacter jejuni
Placebo Comparator: 2
Placebo vaccination followed by challenge with campylobacter jejuni
Biological: Placebo vaccine
Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
Other Name: Campylobacter jejuni

Outcome Measures

Primary Outcome Measures :
  1. Incidence of Moderate or Severe Diarrhea [ Time Frame: 20 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859716

United States, Maryland
Shin Nippon Biomedical Laboratories
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
TD Vaccines A/S
SNBL Clinical Pharmacology Center, Inc.
Johns Hopkins University
University of Vermont
SGS U.S. Testing Company Inc.
Fulcrum Pharma (Europe) Ltd
Principal Investigator: Mohamed Al-Ibrahim, MD Shin Nippon Biomedical Laboratories
More Information

Responsible Party: Ingelise Saunders/CEO, ACE BioSciences A/S
ClinicalTrials.gov Identifier: NCT00859716     History of Changes
Other Study ID Numbers: ACE393-103
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009

Keywords provided by TD Vaccines A/S:
Traveler's Diarrhea
Campylobacter jejuni
C. jejuni

Additional relevant MeSH terms:
Campylobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs