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Title
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A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su
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Author
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Abstract
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| Background: The risk of developing hefpes zoster (HZ) increases with age and is thought to be associated with a decrease in cell-mediated immunity in older adults. The adjuvanted varicella-zoster virus (VZV) glycoprotein E (gE) recombinant subunit vaccine (HZ/su) showed >90% efficacy in the prevention of HZ when administered in adults >= 50 years of age. Here we aim to evaluate immunogenicity consistency of 3 different HZ/su vaccine lots and to assess safety of these lots. Methods: This multicenter, phase III, double-blind, randomized study (NCT02075515), assessed lot-to-lot consistency in terms of immunogenicity of HZ/su and also assessed safety of these lots. Participants aged 50 years or older were randomized (1:1:1) to receive 2 doses of HZ/su, 2 months apart, from 1 out of 3 randomized HZ/su lots (Lots A, B and C). Humoral immunogenicity was assessed pre-vaccination and 1 month post-second vaccination by anti-gE antibody enzyme-linked immunosorbent assay. Lot-to-lot consistency was demonstrated if the 2-sided 95% confidence intervals of the anti-gE geometric mean concentration ratio between all lot pairs were within 0.67 and 1.5. Solicited symptoms were recorded within 7 days and unsolicited adverse events (AEs) within 30 days after each vaccination. Serious AEs (SAEs) and potential immune-mediated diseases (pIMDs) were reported until study end (12 months post-second vaccination). Results: Of 651 participants enrolled in the study, 638 received both doses of the HZ/su vaccine and 634 completed the study. Humoral immune responses were robust and consistency between 3 manufacturing lots was demonstrated. The incidence of solicited symptoms, unsolicited AEs and SAEs was comparable between all lots. Three fatal SAEs, 1 in each lot, were reported, none of which were considered vaccine related by investigator assessment. Two out of the 8 reported pIMDs were considered vaccine-related by the investigator. Conclusion: The three HZ/su manufacturing lots demonstrated consistent immunogenicity. No safety concerns were identified. (C) 2017 GlaxoSmithKline SA. Published by Elsevier Ltd. |
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Language
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English
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Source (journal)
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Vaccine / International Society for Vaccines. - Amsterdam
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Publication
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Amsterdam
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2017
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ISSN
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0264-410X
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DOI
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10.1016/J.VACCINE.2017.10.017
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Volume/pages
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35
:48B
(2017)
, p. 6700-6706
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ISI
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000418224200019
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Pubmed ID
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29079101
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Full text (Publisher's DOI)
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Full text (open access)
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