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

NCT00653627 | Completed Phase 1 DMC

• 2 other identifiers: TB015COREC Number: 07/Q1604/3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Quantification of BCG after BCG vaccination

  2 or 4 weeks

Secondary Outcomes (1)

• Immunogenicity of BCG vaccination

  2 or 4 weeks

Study Arms (2)

A

EXPERIMENTAL

Study of BCG quantification and immunogenicity 2 weeks after BCG vaccination

Biological: BCG

B

EXPERIMENTAL

Study of BCG quantification and immunogenicity 4 weeks after BCG vaccination

Biological: BCG

Interventions

BCG BIOLOGICAL

Mycobacterium bovis Bacille Calmette-Guerin

A; B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen McShane

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 1, 2010

Record last verified: 2010-06

Locations

GB (1)