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Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection

NCT01074775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2010-02-24

No results posted yet for this study

Summary

The approach we will use is to employ measurement of the activation of white blood cells, to look at patterns of responses during a controlled infection of the gut with Mycobacterium bovis. M. bovis can be conveniently obtained in a safe and pure form as an oral vaccine. By giving three challenges of M bovis to the gut, we will simulate repeated gut infections with this organism. We can then compare the activation of cells in the blood to the immune responses seen after each challenge, to determine whether the non-specific defences of the gut can block each subsequent infection.

Conditions

Interventions

BIOLOGICAL

Gut infection challenge with M bovis

Oral delivery of 100mg viable M bovis (approximately 10,000,000 viable bacilli) in 5mL 1.5% sodium glutamate solution on three occasions on days 0, 28 and 49

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Fundação Ataulpho de Paiva, Rio de Janeiro, Brasil

    collaborator UNKNOWN

  • Foundation for the National Institutes of Health

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · St George's - University of London, UK

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT01074775 on ClinicalTrials.gov