A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination - Full Text View

Sponsored by:	University of Oxford
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00653627

Purpose

This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site.

Volunteers will be vaccinated with BCG. The first 8 will go on to have a punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A) the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods of mycobacterial quantification on these tissue samples will then be compared

Condition	Intervention	Phase
Tuberculosis	Biological: BCG	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	A Human Pilot Study to Quantify BCG From the BCG Vaccination Site, and to More Fully Characterise the Immune Response to BCG

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

Quantification of BCG after BCG vaccination [ Time Frame: 2 or 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity of BCG vaccination [ Time Frame: 2 or 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Study of BCG quantification and immunogenicity 2 weeks after BCG vaccination	Biological: BCG Mycobacterium bovis Bacille Calmette-Guerin
B: Experimental Study of BCG quantification and immunogenicity 4 weeks after BCG vaccination	Biological: BCG Mycobacterium bovis Bacille Calmette-Guerin

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Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject is willing and able to give informed consent for participation in the study
Male or Female, aged 18 to 50 years
In good health
BCG-naïve
Screening elispot negative (less than 17 spot forming cells per million PBMC) for ESAT 6 and CFP 10 peptide pools
Resident in or near Oxford for the duration of the study
Female patient/subjects of child bearing potential must be willing to ensure that they practice effective contraception use during the study.
Subject has clinically acceptable laboratory results from Pre Study Screen
Able (in the Investigators opinion) and willing to comply with all study requirements
Willing to allow his or her General Practitioner to be notified of participation in the study

Exclusion Criteria:

Previous BCG vaccination
Female subject who is pregnant, lactating or planning pregnancy during the course of the study
Persons suffering from malignant conditions (e.g., lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticulo-endothelial system), primary or secondary immunodeficiencies, HIV infection, or moderate/severe dermatological conditions
Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed)
Any history of severe allergic reaction or anaphylaxis in reaction to vaccination
Administration of immunoglobulins or donation of blood products during the study or within the past 12 weeks
Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of >42 units a week)
Any on-going chronic illness requiring hospital specialist supervision
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
Subjects who have participated in another research study involving an investigational product in the past 12 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653627

Contacts

Contact: Angela Minassian

01865 857425

angela.minassian@ndm.ox.ac.uk

Locations

United Kingdom
CCVTM, University of Oxford	Recruiting
Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

University of Oxford

Investigators

Principal Investigator:

Helen McShane

University of Oxford

More Information

No publications provided

Responsible Party:	University of Oxford ( Dr Helen McShane )
Study ID Numbers:	TB015, COREC Number: 07/Q1604/3
Study First Received:	April 2, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00653627 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 10, 2009