Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01074775
• Date of registration: 23/02/2010
• Prospective Registration: No
• Primary sponsor: St George's, University of London
• Public title: Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection UBC-INNATE01
• Scientific title: An Investigation Of In Vivo Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection
• Date of first enrolment: September 2006
• Target sample size: 7
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01074775
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: St George's - University of London, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult volunteers, 18 to 45 years of age, who sign an informed consent form following
a detailed explanation of participation in the protocol.

- Volunteers who are in good health as determined by medical history, physical
examination and clinical judgement.

- Volunteers who will be available for the duration of the study.

- Volunteers willing and able to give written informed consent.

Exclusion Criteria:

- Volunteers who are contraindicated for BCG vaccination according to the
Manufacturer's Data Sheet.

- Individuals who have hypersensitivity to any component of the vaccine used in this
study.

- Individuals who have severe or multiple allergies, including to drugs or
pharmaceutical agents.

- Volunteers who are receiving drug treatment for, or who have a significant history
of, cardiological or respiratory disease. Volunteers who are suffering from severe
cardio-respiratory disease, including hypertension, or an active neurological
disorder.

- Individuals found to be HIV antibody positive at screening, or with a known
impairment of immune function, or those receiving immunosuppressive therapy,
including regular inhaled steroids. Intermittent steroid use (less than twice per
month in the preceding 3 months) is acceptable.

- Individuals with acute infections (including fever >38°C).

- Women who are pregnant or lactating.

- Women capable of becoming pregnant who do not agree to have pregnancy testing before
immunisation, and/or who do not agree to take effective contraception for the
duration of the study period.

- Individuals with a current problem with substance abuse or with a history of
substance abuse, which, in the opinion of the investigator, might interfere with
participation in the study.

- Individuals with any condition, which, in the opinion of the investigator, might
interfere with the evaluation with the study objectives.

- Individuals who have received an investigational agent within 30 days prior to entry,
or been in any other study in the last 6 months.

- Individuals who are planning to leave the area of the study site prior to the end of
the study period, or who are likely not to complete the study.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bacterial Infections

Intervention(s)

Biological: Gut infection challenge with M bovis

Primary Outcome(s)

Genomics profile [Time Frame: 12 months (23 visits)]

Secondary Outcome(s)

Cell mediated immune responses [Time Frame: 12 months (8 visits)]

Secondary ID(s)

UBC-INNATE01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Wellcome Trust

University of British Columbia

Bill and Melinda Gates Foundation

Foundation for the National Institutes of Health

Fundação Ataulpho de Paiva, Rio de Janeiro, Brasil