A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
|First Received Date ICMJE||May 30, 2007|
|Last Updated Date||May 30, 2007|
|Start Date ICMJE||March 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The induction of T-cell responses [ Time Frame: 6 months ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers|
|Official Title ICMJE||A Study of the Immunogenicity of M. Bovis BCG (SSI Strain), Delivered Intradermally in Healthy Volunteers|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Intervention ICMJE||Biological: BCG (SSI Strain)|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00480714|
|Other Study ID Numbers ICMJE||TB003|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Oxford|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Oxford|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP