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Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

NCT00434798 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-06-05

No results posted yet for this study

Summary

The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:

1. Safe application

1. Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
2. Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
2. Campylobacteriosis attack rate of at least 75%

Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in the newly established human C. jejuni infection model and evaluate short-term (\< 3 mo) protection upon repeat exposure to homologous C. jejuni strain and assess immune responses associated with protection.

Conditions

  • Campylobacter Infections

Interventions

BIOLOGICAL

Campylobacter jejuni strains CG8421 and BH-01-0142

Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10\^6-10\^9 CFU

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • TD Vaccines A/S

    collaborator INDUSTRY

  • University of Vermont

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434798 on ClinicalTrials.gov