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

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00653627
First received: April 2, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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 ]

Enrollment: 40
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Study of BCG quantification and immunogenicity 2 weeks after BCG vaccination
 Biological: BCG
Mycobacterium bovis Bacille Calmette-Guerin
Experimental: B
Study of BCG quantification and immunogenicity 4 weeks after BCG vaccination
 Biological: BCG
Mycobacterium bovis Bacille Calmette-Guerin

  Show Detailed Description

  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

Locations
United Kingdom
CCVTM, University of Oxford
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: Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier: NCT00653627     History of Changes
Other Study ID Numbers: TB015, COREC Number: 07/Q1604/3
Study First Received: April 2, 2008
Last Updated: June 30, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 18, 2013