First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults
| Journal Title: | Vaccine 2015, Vol.33 (33), p.4130-4140 |
| Main Author: | Luabeya, Angelique Kany Kany |
| Other Authors: | Kagina, Benjamin M.N , Tameris, Michele D , Geldenhuys, Hennie , Hoff, Soren T , Shi, Zhongkai , Kromann, Ingrid , Hatherill, Mark , Mahomed, Hassan , Hanekom, Willem A , Andersen, Peter , Scriba, Thomas J , Schoeman, Elisma , Krohn, Colleen , Day, Cheryl L , Africa, Hadn , Makhethe, Lebohang , Smit, Erica , Brown, Yolande , Suliman, Sara , Hughes, E. Jane , Bang, Peter , Snowden, Margaret A , McClain, Bruce , Hussey, Gregory D |
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 Electronic Article
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| Language: |
English |
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| Quelle: | Alma/SFX Local Collection |
| Publisher: | Netherlands: Elsevier Ltd |
| ID: | ISSN: 0264-410X |
| Link: | https://www.ncbi.nlm.nih.gov/pubmed/26095509 |
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| recordid: | cdi_proquest_miscellaneous_1702659112 |
| title: | First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults |
| format: | Article |
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| ispartof: | Vaccine, 2015, Vol.33 (33), p.4130-4140 |
| description: | Abstract Background H56:IC31 is a candidate tuberculosis vaccine comprising a fusion protein of Ag85B, ESAT-6 and Rv2660c, formulated in IC31 adjuvant. This first-in-human, open label phase I trial assessed the safety and immunogenicity of H56:IC31 in healthy adults without or with Mycobacterium tuberculosis ( M.tb ) infection. Methods Low dose (15 μg H56 protein in 500 nmol IC31) or high dose (50 μg H56, 500 nmol IC31) vaccine was administered intramuscularly thrice, at 56-day intervals. Antigen-specific T cell responses were measured by intracellular cytokine staining and antibody responses by ELISA. Results One hundred and twenty-six subjects were screened and 25 enrolled and vaccinated. No serious adverse events were reported. Nine subjects (36%) presented with transient cardiovascular adverse events. The H56:IC31 vaccine induced antigen-specific IgG responses and Th1 cytokine-expressing CD4+ T cells. M.tb -infected vaccinees had higher frequencies of H56-induced CD4+ T cells than uninfected vaccinees. Low dose vaccination induced more polyfunctional (IFN-γ+ TNF-α+ IL-2+ ) and higher frequencies of H56-specific CD4+ T cells compared with high dose vaccination. A striking increase in IFN-γ-only-expressing CD4+ T cells, displaying a CD45RA− CCR7− effector memory phenotype, emerged after the second high-dose vaccination in M.tb -infected vaccinees. TNF-α+ IL-2+ H56-specific memory CD4+ T cells were detected mostly after low-dose H56 vaccination in M.tb -infected vaccinees, and predominantly expressed a CD45RA− CCR7+ central memory phenotype. Our results support further clinical testing of H56:IC31. |
| language: | eng |
| source: | Alma/SFX Local Collection |
| identifier: | ISSN: 0264-410X |
| fulltext: | fulltext |
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| url: | Link |
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