H1:IC31 vaccination is safe and induces long-lived TNF-a+ IL-2+ CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trial

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dc.contributor.authorMearns, Helen
dc.contributor.authorGeldenhuys, Hennie D.
dc.contributor.authorKagina, Benjamin M.
dc.contributor.authorRatangee, Frances
dc.contributor.authorMauff, Katya
dc.date.accessioned2023-02-15T20:02:58Z
dc.date.available2023-02-15T20:02:58Z
dc.date.issued2017
dc.description.abstractControl of the tuberculosis epidemic requires a novel vaccine that is effective in preventing tuberculosis in adolescents, a key target population for vaccination against TB. Healthy adolescents, stratified by M. tuberculosis-infection status, were enrolled into this observer-blinded phase II clinical trial of the protein-subunit vaccine candidate, H1:IC31, comprising a fusion protein (H1) of Ag85B and ESAT-6, formulated with the IC31 adjuvant. Local and systemic adverse events and induced T cell responses were measured after one or two administrations of either 15μg or 50μg of the H1 protein. Two hundred and forty participants were recruited and followed up for 224days. No notable safety events were observed regardless of H1 dose or vaccination schedule. H1:IC31 vaccination induced antigen-specific CD4 T cells, co-expressing IFN-γ, TNF-α and/or IL-2. H1:IC31 vaccination of M.tb-uninfected individuals preferentially drove the emergence of Ag85B and ESAT-6 specific TNF-α+IL-2+CD4 T cells, while H1:IC31 vaccination of M.tb-infected individuals resulted in the expansion of Ag85B-specific but not ESAT-6–specific TNF-α+IL-2+CD4 T cells. H1:IC31 was safe and immunogenic in uninfected and M.tb-infected adolescents. Two administrations of the 15μg H1:IC31 dose induced the greatest magnitude immune response, and was considered optimal .en_US
dc.identifier.citationMearns, H., Geldenhuys, H. D., Kagina, B. M., Musvosvi, M., Little, F., Ratangee, F., ... & Steyn, M. (2017). H1: IC31 vaccination is safe and induces long-lived TNF-α+ IL-2+ CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trial. Vaccine, 35(1), 132-141.https://doi.org/10.1016/j.vaccine.2016.11.023en_US
dc.identifier.issn0264-410X
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/7817
dc.language.isoenen_US
dc.publisherVaccineen_US
dc.subjectRandomiseden_US
dc.subjectClinical trialen_US
dc.subjectH1:IC31en_US
dc.subjectMycobacterium tuberculosisen_US
dc.titleH1:IC31 vaccination is safe and induces long-lived TNF-a+ IL-2+ CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trialen_US
dc.typeArticleen_US
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