First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults

Simple item page
dc.contributor.authorLuabeya, Angelique Kany Kany
dc.contributor.authorKagina, Benjamin M.N.
dc.contributor.authorKromann, Ingrid
dc.contributor.authorMahomed, Hassan
dc.contributor.authorHanekom, Willem A.
dc.date.accessioned2023-02-15T19:57:09Z
dc.date.available2023-02-15T19:57:09Z
dc.date.issued2015
dc.description.abstractH56: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. Low dose (15μg H56 protein in 500nmol IC31) or high dose (50μg H56, 500nmol 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. 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.en_US
dc.identifier.citationLuabeya, A. K. K., Kagina, B. M., Tameris, M. D., Geldenhuys, H., Hoff, S. T., Shi, Z., ... & H56-032 Trial Study Group. (2015). First-in-human trial of the post-exposure tuberculosis vaccine H56: IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults. Vaccine, 33(33), 4130-4140.https://doi.org/10.1016/j.vaccine.2015.06.051en_US
dc.identifier.issn0264-410X
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/7816
dc.language.isoenen_US
dc.publisherVaccineen_US
dc.subjectTuberculosisen_US
dc.subjectVaccineen_US
dc.subjectLatenten_US
dc.subjectClinical trialen_US
dc.titleFirst-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adultsen_US
dc.typeArticleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
First-in-human trial of the post-exposure tuberculosis vaccine H56IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults.pdf
Size:
3.44 MB
Format:
Adobe Portable Document Format
Description:
First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Medical and Health Sciences