ACE393-103 Vaccination Challenge Study

Campylobacter Infection Clinical Trial

— ACE393-103VC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00859716
• Other study ID #: ACE393-103
• Secondary ID: BB013742
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 10, 2009
• Last updated: March 10, 2009
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2009
• Source: TD Vaccines A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Campylobacter Infection
• Campylobacter Infections

Intervention

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

Locations

Country	Name	City	State
United States	Shin Nippon Biomedical Laboratories	Baltimore	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
TD Vaccines A/S	Fulcrum Pharma (Europe) Ltd, Johns Hopkins University, SGS U.S. Testing Company Inc., SNBL Clinical Pharmacology Center, Inc., University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Moderate or Severe Diarrhea		20 weeks	No
Secondary	Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)		20 Weeks	No
Secondary	Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)		20 weeks	No
Secondary	Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)		20 weeks	No
Secondary	Incidence of severe diarrhea		20 weeks	No