A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers - Full Text View

Sponsored by:	University of Oxford
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00480688

Purpose

To assess the immunogenicity of M. bovis BCG, given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.

Condition	Intervention	Phase
TB	Biological: BCG	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers

Further study details as provided by University of Oxford:

Primary Outcome Measures:

Induction of T cell responses [ Time Frame: 6 months ]

Enrollment:	11
Study Start Date:	November 2001
Study Completion Date:	May 2002

Detailed Description:

Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing.

Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment. Volunteers will give signed consent for their GP’s to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult aged 18-65 years.
Normal medical history and physical examination.
Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion Criteria:

Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy,immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder,liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
Oral or systemic steroid medication or the use of immunosuppressive agents.
Positive HIV or core HBV antibody test.
Positive Heaf test
Positive ANA or serum anti-DNA antibody.
Confirmed pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480688

Locations

United Kingdom, Oxfordshire
University of Oxford, CCVTM, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Sponsors and Collaborators

University of Oxford

Investigators

Principal Investigator:

Helen I McShane

University of Oxford

More Information

Publications of Results:

McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. Epub 2004 Oct 24. Erratum in: Nat Med. 2004 Dec;10(12):1397.

Study ID Numbers:	TB001
Study First Received:	May 30, 2007
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00480688
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:

TB
BCG

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009