A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults.
RATIONALE: Novel tuberculosis (TB) vaccines should be safe and effective in populations infected with Mycobacterium tuberculosis (M.tb) and/or HIV for effective TB control. OBJECTIVE: To determine the safety and immunogenicity of MVA85A, a novel TB vaccine, among M.tb- and/or HIV-infected persons in...
| Үндсэн зохиолчид: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Формат: | Journal article |
| Хэл сонгох: | English |
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2012
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| _version_ | 1826273358739668992 |
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| author | Scriba, T Tameris, M Smit, E van der Merwe, L Hughes, E Kadira, B Mauff, K Moyo, S Brittain, N Lawrie, A Mulenga, H de Kock, M Makhethe, L Janse van Rensburg, E Gelderbloem, S Veldsman, A Hatherill, M Geldenhuys, H Hill, A Hawkridge, A Hussey, G Hanekom, W McShane, H Mahomed, H |
| author_facet | Scriba, T Tameris, M Smit, E van der Merwe, L Hughes, E Kadira, B Mauff, K Moyo, S Brittain, N Lawrie, A Mulenga, H de Kock, M Makhethe, L Janse van Rensburg, E Gelderbloem, S Veldsman, A Hatherill, M Geldenhuys, H Hill, A Hawkridge, A Hussey, G Hanekom, W McShane, H Mahomed, H |
| author_sort | Scriba, T |
| collection | OXFORD |
| description | RATIONALE: Novel tuberculosis (TB) vaccines should be safe and effective in populations infected with Mycobacterium tuberculosis (M.tb) and/or HIV for effective TB control. OBJECTIVE: To determine the safety and immunogenicity of MVA85A, a novel TB vaccine, among M.tb- and/or HIV-infected persons in a setting where TB and HIV are endemic. METHODS: An open-label, phase IIa trial was conducted in 48 adults with M.tb and/or HIV infection. Safety and immunogenicity were analyzed up to 52 weeks after intradermal vaccination with 5 × 10(7) plaque-forming units of MVA85A. Specific T-cell responses were characterized by IFN-γ enzyme-linked immunospot and whole blood intracellular cytokine staining assays. MEASUREMENTS AND MAIN RESULTS: MVA85A was well tolerated and no vaccine-related serious adverse events were recorded. MVA85A induced robust and durable response of mostly polyfunctional CD4(+) T cells, coexpressing IFN-γ, tumor necrosis factor-α, and IL-2. Magnitudes of pre- and postvaccination T-cell responses were lower in HIV-infected, compared with HIV-uninfected, vaccinees. No significant effect of antiretroviral therapy on immunogenicity of MVA85A was observed. CONCLUSIONS: MVA85A was safe and immunogenic in persons with HIV and/or M.tb infection. These results support further evaluation of safety and efficacy of this vaccine for prevention of TB in these target populations. |
| first_indexed | 2024-03-06T22:26:58Z |
| format | Journal article |
| id | oxford-uuid:56faaaa7-18af-4ab2-9293-960f3aba3c73 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:26:58Z |
| publishDate | 2012 |
| record_format | dspace |
| spelling | oxford-uuid:56faaaa7-18af-4ab2-9293-960f3aba3c732022-03-26T16:53:53ZA phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:56faaaa7-18af-4ab2-9293-960f3aba3c73EnglishSymplectic Elements at Oxford2012Scriba, TTameris, MSmit, Evan der Merwe, LHughes, EKadira, BMauff, KMoyo, SBrittain, NLawrie, AMulenga, Hde Kock, MMakhethe, LJanse van Rensburg, EGelderbloem, SVeldsman, AHatherill, MGeldenhuys, HHill, AHawkridge, AHussey, GHanekom, WMcShane, HMahomed, HRATIONALE: Novel tuberculosis (TB) vaccines should be safe and effective in populations infected with Mycobacterium tuberculosis (M.tb) and/or HIV for effective TB control. OBJECTIVE: To determine the safety and immunogenicity of MVA85A, a novel TB vaccine, among M.tb- and/or HIV-infected persons in a setting where TB and HIV are endemic. METHODS: An open-label, phase IIa trial was conducted in 48 adults with M.tb and/or HIV infection. Safety and immunogenicity were analyzed up to 52 weeks after intradermal vaccination with 5 × 10(7) plaque-forming units of MVA85A. Specific T-cell responses were characterized by IFN-γ enzyme-linked immunospot and whole blood intracellular cytokine staining assays. MEASUREMENTS AND MAIN RESULTS: MVA85A was well tolerated and no vaccine-related serious adverse events were recorded. MVA85A induced robust and durable response of mostly polyfunctional CD4(+) T cells, coexpressing IFN-γ, tumor necrosis factor-α, and IL-2. Magnitudes of pre- and postvaccination T-cell responses were lower in HIV-infected, compared with HIV-uninfected, vaccinees. No significant effect of antiretroviral therapy on immunogenicity of MVA85A was observed. CONCLUSIONS: MVA85A was safe and immunogenic in persons with HIV and/or M.tb infection. These results support further evaluation of safety and efficacy of this vaccine for prevention of TB in these target populations. |
| spellingShingle | Scriba, T Tameris, M Smit, E van der Merwe, L Hughes, E Kadira, B Mauff, K Moyo, S Brittain, N Lawrie, A Mulenga, H de Kock, M Makhethe, L Janse van Rensburg, E Gelderbloem, S Veldsman, A Hatherill, M Geldenhuys, H Hill, A Hawkridge, A Hussey, G Hanekom, W McShane, H Mahomed, H A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title | A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title_full | A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title_fullStr | A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title_full_unstemmed | A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title_short | A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. |
| title_sort | phase iia trial of the new tuberculosis vaccine mva85a in hiv and or mycobacterium tuberculosis infected adults |
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