NCT00859716

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

Enrollment Period

5 months

First QC Date

March 10, 2009

Last Update Submit

March 10, 2009

Conditions

Campylobacter Infection

Keywords

VaccinationDiarrheaTraveler's DiarrheaCampylobacter jejuniC. jejuniCampylobacterCampy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Moderate or Severe Diarrhea

    20 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

vaccination with ACE393 followed by challenge with campylobacter jejuni

Biological: ACE393

2

PLACEBO COMPARATOR

Placebo vaccination followed by challenge with campylobacter jejuni

Biological: Placebo vaccine

Interventions

ACE393BIOLOGICAL

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

Also known as: Campylobacter jejuni
1
Placebo vaccineBIOLOGICAL

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

Also known as: Campylobacter jejuni
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Nippon Biomedical Laboratories

Baltimore, Maryland, 21201, United States

Location

Related Links

MeSH Terms

Conditions

Campylobacter InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Al-Ibrahim, MD

    Shin Nippon Biomedical Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

March 11, 2009

Record last verified: 2009-03

Locations

US(1)