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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by TD Vaccines A/S.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
SNBL Clinical Pharmacology Center Inc.
Johns Hopkins University
University of Vermont
SGS U.S. Testing Company Inc.
Fulcrum Pharma (Europe) Ltd
Information provided by:
TD Vaccines A/S
ClinicalTrials.gov Identifier:
NCT00859716
First received: March 10, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 10, 2009
March 10, 2009
October 2008
March 2009   (final data collection date for primary outcome measure)
Incidence of Moderate or Severe Diarrhea [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Incidence of severe diarrhea [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ACE393-103 Vaccination Challenge 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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Campylobacter Infection
  • Biological: ACE393
    ACE393 250 micrograms as intra muscular injection at day 0 and day 21
    Other Name: Campylobacter jejuni
  • Biological: Placebo vaccine
    Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
    Other Name: Campylobacter jejuni
  • Experimental: 1
    vaccination with ACE393 followed by challenge with campylobacter jejuni
    Intervention: Biological: ACE393
  • Placebo Comparator: 2
    Placebo vaccination followed by challenge with campylobacter jejuni
    Intervention: Biological: Placebo vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
July 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00859716
ACE393-103, BB013742
Yes
Ingelise Saunders/CEO, ACE BioSciences A/S
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
TD Vaccines A/S
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP