ACE393-103 Vaccination Challenge Study

NCT ID: NCT00859716

Last Updated: 2009-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

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.

Conditions

Campylobacter Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

vaccination with ACE393 followed by challenge with campylobacter jejuni

Group Type: EXPERIMENTAL

ACE393

Intervention Type: BIOLOGICAL

ACE393 250 micrograms as intra muscular injection at day 0 and day 21

2

Placebo vaccination followed by challenge with campylobacter jejuni

Group Type: PLACEBO_COMPARATOR

Placebo vaccine

Intervention Type: BIOLOGICAL

Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Interventions

ACE393

ACE393 250 micrograms as intra muscular injection at day 0 and day 21

Intervention Type: BIOLOGICAL

Placebo vaccine

Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Intervention Type: BIOLOGICAL

Other Intervention Names

Campylobacter jejuni; Campylobacter jejuni

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SNBL Clinical Pharmacology Center, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

SGS U.S. Testing Company Inc.

INDUSTRY

Sponsor Role: collaborator

Fulcrum Pharma (Europe) Ltd

UNKNOWN

Sponsor Role: collaborator

TD Vaccines A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

ACE BioSciences A/S

Principal Investigators

Mohamed Al-Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Nippon Biomedical Laboratories

Locations

Shin Nippon Biomedical Laboratories

Baltimore, Maryland, United States

Countries

United States

Related Links

http://www.acebiosciences.com

Sponsor

Other Identifiers

BB013742

Identifier Type: -

Identifier Source: secondary_id

ACE393-103

Identifier Type: -

Identifier Source: org_study_id