A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00480688|
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : May 31, 2007
|Condition or disease||Intervention/treatment||Phase|
|TB||Biological: BCG||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||May 2002|
- Induction of T cell responses [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480688
|University of Oxford, CCVTM, Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Helen I McShane||University of Oxford|