A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2002-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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TB

Keywords

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TB BCG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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BCG

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Helen I McShane

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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University of Oxford, CCVTM, Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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. doi: 10.1038/nm1128. Epub 2004 Oct 24.

Reference Type RESULT

PMID: 15502839 (View on PubMed)

Other Identifiers

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TB001

Identifier Type: -

Identifier Source: org_study_id