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Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults
Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Infectious Diseases.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centrum för klinisk forskning i Sörmland (CKFD). Karolinska Univ Hosp, Dept Med, Stockholm, Sweden..
Publ Hlth Serv Amsterdam, Dept Infect Dis, Amsterdam, Netherlands..
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2016 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 34, no 6, 863-868 p.Article in journal (Refereed) Published
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Abstract [en]

Background: An investigational subunit vaccine containing the varicella-zoster virus (VZV) glycoprotein E (gE) and the AS01(B) adjuvant system is being evaluated for the prevention of herpes zoster (HZ) in older adults. A phase II trial evaluating different formulations of this vaccine (containing 25 mu g, 50 mu g, or 100 mu g gE) was conducted in adults >= 60 years of age and showed that all formulations elicited robust cellular and humoral immune responses for up to 3 years after vaccination. In this follow-up study in subjects who received two doses of the 50 mu g gE/AS01(B) formulation (HZ/su), we assessed the persistence of the immune responses for up to 6 years after vaccination. Methods: This phase II, open-label, multicenter, single-group trial conducted in the Czech Republic, Germany, Sweden, and the Netherlands followed 129 subjects who had received two doses (2 months apart) of HZ/su during the initial trial. Vaccine-induced immune responses (frequencies of gE-specific CD4(+) T cells expressing >= 2 activation markers and serum anti-gE antibody concentrations) were evaluated at 48, 60, and 72 months after the first HZ/su dose. Results: Six years after vaccination with HZ/su, gE-specific cell-mediated immune responses and anti-gE antibody concentrations had decreased by 20-25% from month 36, but remained higher than the prevaccination values. At month 72, the gE-specific cell-mediated immune response was 3.8 times higher than the prevaccination value (477.3 vs. 119.4 activated gE-specific CD4(+) T cells per 10(6) cells), and the anti-gE antibody concentration was 7.3 times higher than the prevaccination value (8159.0 vs. 1121.3 mIU/mL). No vaccine-related serious adverse events were reported between months 36 and 72. Conclusions: gE-specific cellular and humoral immune responses persisted for 6 years after two-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.

Place, publisher, year, edition, pages
2016. Vol. 34, no 6, 863-868 p.
Keyword [en]
Varicella-zoster virus, Glycoprotein E, Subunit vaccine, lmmunogenicity, Persistence
National Category
Immunology in the medical area
Identifiers
URN: urn:nbn:se:uu:diva-280259DOI: 10.1016/j.vaccine.2015.09.073ISI: 000370108500022PubMedID: 26432913OAI: oai:DiVA.org:uu-280259DiVA: diva2:910457
Funder
GlaxoSmithKline (GSK)
Available from: 2016-03-09 Created: 2016-03-09 Last updated: 2017-05-04Bibliographically approved

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Pauksens, Karlis

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