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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00653627
• Date of registration: 02/04/2008
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination
• Scientific title: A Human Pilot Study to Quantify BCG From the BCG Vaccination Site, and to More Fully Characterise the Immune Response to BCG
• Date of first enrolment: August 2007
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00653627
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: BCG

Primary Outcome(s)

Quantification of BCG after BCG vaccination [Time Frame: 2 or 4 weeks]

Secondary Outcome(s)

Immunogenicity of BCG vaccination [Time Frame: 2 or 4 weeks]

Secondary ID(s)

TB015

COREC Number: 07/Q1604/3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors