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

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.

Study Overview

• Status: Unknown
• Conditions: Campylobacter Infection
• Intervention / Treatment: Biological: ACE393; Biological: Placebo vaccine

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Shin Nippon Biomedical Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Campylobacter jejuni

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Moderate or Severe Diarrhea	20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)	20 Weeks
Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)	20 weeks
Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)	20 weeks
Incidence of severe diarrhea	20 weeks

Collaborators and Investigators

• Sponsor: TD Vaccines A/S
• Collaborators: Johns Hopkins University; University of Vermont; SNBL Clinical Pharmacology Center, Inc.; SGS U.S. Testing Company Inc.; Fulcrum Pharma (Europe) Ltd
• Investigators: Principal Investigator: Mohamed Al-Ibrahim, MD, Shin Nippon Biomedical Laboratories

Publications and helpful links

Helpful Links

• Sponsor

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ANTICIPATED): March 1, 2009
• Study Completion (ANTICIPATED): July 1, 2009

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (ESTIMATE): March 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2009
• Last Update Submitted That Met QC Criteria: March 10, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Diarrhea; Vaccination; Campylobacter jejuni; Traveler's Diarrhea; Campylobacter; C. jejuni; Campy
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Campylobacter Infections
• Other Study ID Numbers: ACE393-103; BB013742