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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653627
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : July 1, 2010
Information provided by:
University of Oxford

Brief Summary:
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 or disease Intervention/treatment Phase
Tuberculosis Biological: BCG Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quantification of BCG after BCG vaccination [ Time Frame: 2 or 4 weeks ]

Secondary Outcome Measures :
  1. Immunogenicity of BCG vaccination [ Time Frame: 2 or 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00653627

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United Kingdom
CCVTM, University of Oxford
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
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Principal Investigator: Helen McShane University of Oxford
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Responsible Party: Dr Helen McShane, University of Oxford Identifier: NCT00653627    
Other Study ID Numbers: TB015
COREC Number: 07/Q1604/3
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections