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

Primary Purpose

Campylobacter Infection

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACE393
Placebo vaccine
Sponsored by
TD Vaccines A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Campylobacter Infection focused on measuring Vaccination, Diarrhea, Traveler's Diarrhea, Campylobacter jejuni, C. jejuni, Campylobacter, Campy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shin Nippon Biomedical Laboratories

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

vaccination with ACE393 followed by challenge with campylobacter jejuni

Placebo vaccination followed by challenge with campylobacter jejuni

Outcomes

Primary Outcome Measures

Incidence of Moderate or Severe Diarrhea

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2009
Last Updated
March 10, 2009
Sponsor
TD Vaccines A/S
Collaborators
SNBL Clinical Pharmacology Center, Inc., Johns Hopkins University, University of Vermont, SGS U.S. Testing Company Inc., Fulcrum Pharma (Europe) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00859716
Brief Title
ACE393-103 Vaccination Challenge Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Campylobacter Infection
Keywords
Vaccination, Diarrhea, Traveler's Diarrhea, Campylobacter jejuni, C. jejuni, Campylobacter, Campy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
vaccination with ACE393 followed by challenge with campylobacter jejuni
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo vaccination followed by challenge with campylobacter jejuni
Intervention Type
Biological
Intervention Name(s)
ACE393
Other Intervention Name(s)
Campylobacter jejuni
Intervention Description
ACE393 250 micrograms as intra muscular injection at day 0 and day 21
Intervention Type
Biological
Intervention Name(s)
Placebo vaccine
Other Intervention Name(s)
Campylobacter jejuni
Intervention Description
Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
Primary Outcome Measure Information:
Title
Incidence of Moderate or Severe Diarrhea
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Median Total (individual) stool number (grade 3-5 stools, diarrheal episodes only)
Time Frame
20 Weeks
Title
Median Total (individual) stool volume (grade 3-5 stools, diarrheal episodes only)
Time Frame
20 weeks
Title
Maximum stool number and volume in a 24 hr period (grade 3-5 stools, diarrheal episodes only)
Time Frame
20 weeks
Title
Incidence of severe diarrhea
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Al-Ibrahim, MD
Organizational Affiliation
Shin Nippon Biomedical Laboratories
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Nippon Biomedical Laboratories
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.acebiosciences.com
Description
Sponsor

Learn more about this trial

ACE393-103 Vaccination Challenge Study

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