Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480714
Status:
COMPLETED
Last Update Posted:
2007-05-31
First Post:
2007-05-30
Brief Title:
A Study of the Immunogenicity of BCG Delivered Intradermally in Healthy Volunteers
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Study of the Immunogenicity of M Bovis BCG SSI Strain Delivered Intradermally in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 GPs 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 01ml 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 ie
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
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 GPs 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 01ml 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 ie
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None