Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design.
Tuberculosis remains a substantial global health problem despite effective drug treatments. The efficacy of BCG, the only available vaccine, is variable, especially in tuberculosis-endemic regions. Recent advances in the development of new vaccines against tuberculosis mean that the first of these a...
| Main Authors: | , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
2006
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| _version_ | 1797085179365294080 |
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| author | Ibanga, H Brookes, R Hill, P Owiafe, P Fletcher, H Lienhardt, C Hill, A Adegbola, R Mcshane, H |
| author_facet | Ibanga, H Brookes, R Hill, P Owiafe, P Fletcher, H Lienhardt, C Hill, A Adegbola, R Mcshane, H |
| author_sort | Ibanga, H |
| collection | OXFORD |
| description | Tuberculosis remains a substantial global health problem despite effective drug treatments. The efficacy of BCG, the only available vaccine, is variable, especially in tuberculosis-endemic regions. Recent advances in the development of new vaccines against tuberculosis mean that the first of these are now entering into early clinical trials. A recombinant modified vaccinia virus Ankara expressing a major secreted antigen from Mycobacterium tuberculosis, antigen 85A, was the first new tuberculosis vaccine to enter into clinical trials in September 2002. This vaccine is known as MVA85A. In a series of phase I clinical trials in the UK, MVA85A had an excellent safety profile and was highly immunogenic. MVA85A was subsequently evaluated in a series of phase I trials in The Gambia, a tuberculosis-endemic area in west Africa. This vaccine is the only new subunit tuberculosis vaccine to enter into clinical trials in Africa to date. Here, we discuss some of the issues that were considered in the protocol design of these studies including recruitment, inclusion and exclusion criteria, reimbursement of study participants, and HIV testing. These issues are highly relevant to early clinical trials with all new tuberculosis vaccines in the developing world. |
| first_indexed | 2024-03-07T02:05:19Z |
| format | Journal article |
| id | oxford-uuid:9ecb9424-8d34-4cea-854e-bbd159cf42dc |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T02:05:19Z |
| publishDate | 2006 |
| record_format | dspace |
| spelling | oxford-uuid:9ecb9424-8d34-4cea-854e-bbd159cf42dc2022-03-27T00:52:36ZEarly clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:9ecb9424-8d34-4cea-854e-bbd159cf42dcEnglishSymplectic Elements at Oxford2006Ibanga, HBrookes, RHill, POwiafe, PFletcher, HLienhardt, CHill, AAdegbola, RMcshane, HTuberculosis remains a substantial global health problem despite effective drug treatments. The efficacy of BCG, the only available vaccine, is variable, especially in tuberculosis-endemic regions. Recent advances in the development of new vaccines against tuberculosis mean that the first of these are now entering into early clinical trials. A recombinant modified vaccinia virus Ankara expressing a major secreted antigen from Mycobacterium tuberculosis, antigen 85A, was the first new tuberculosis vaccine to enter into clinical trials in September 2002. This vaccine is known as MVA85A. In a series of phase I clinical trials in the UK, MVA85A had an excellent safety profile and was highly immunogenic. MVA85A was subsequently evaluated in a series of phase I trials in The Gambia, a tuberculosis-endemic area in west Africa. This vaccine is the only new subunit tuberculosis vaccine to enter into clinical trials in Africa to date. Here, we discuss some of the issues that were considered in the protocol design of these studies including recruitment, inclusion and exclusion criteria, reimbursement of study participants, and HIV testing. These issues are highly relevant to early clinical trials with all new tuberculosis vaccines in the developing world. |
| spellingShingle | Ibanga, H Brookes, R Hill, P Owiafe, P Fletcher, H Lienhardt, C Hill, A Adegbola, R Mcshane, H Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title | Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title_full | Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title_fullStr | Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title_full_unstemmed | Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title_short | Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. |
| title_sort | early clinical trials with a new tuberculosis vaccine mva85a in tuberculosis endemic countries issues in study design |
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