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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00480714
Other study ID # TB003
Secondary ID
Status Completed
Phase N/A
First received May 30, 2007
Last updated May 30, 2007
Start date March 2003
Est. completion date September 2003

Study information

Verified date May 2007
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

To assess the immunogenicity of M. bovis BCG (SSI strain), 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.


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.

A week after the screening visit and after a negative Heaf test, subjects will receive a single intradermal injection of 106 cfu M. bovis BCG in 0.1ml just inferior to the insertion of the deltoid muscle. Blood tests will be taken at the screening visit and day of immunisation, 1 and 2 weeks, and 1, 2, 3 and 6 months after the immunisation. 75mls will be taken on the screening visit, and 60mls will be taken on all subsequent visits. Screening samples will be tested for full blood count, biochemical screen and immunological assays to determine vaccine immunogenicity. Peripheral blood mononuclear cells will be prepared for cellular immunological assays to be performed without or following cryopreservation. Other serological measures of immune response, i.e.

antibody titres, will be assayed on frozen plasma samples. All blood tests will be taken within 1-3 days of the due date as described in the schedule above.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
BCG (SSI Strain)


Locations

Country Name City State
United Kingdom University of Oxford, CCVTM, Churchill Hospital Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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( — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The induction of T-cell responses 6 months
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