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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Induction of T cell responses | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen I McShane | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford, CCVTM, Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15502839 | Result | 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(11):1240-4. doi: 10.1038/nm1128. Epub 2004 Oct 24. |
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