A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers|
- Induction of T cell responses [ Time Frame: 6 months ]
|Study Start Date:||November 2001|
|Study Completion Date:||May 2002|
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.
|University of Oxford, CCVTM, Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Helen I McShane||University of Oxford|