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Long-term immunogen...
Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults
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- Chlibek, Roman (author)
- Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.
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- Pauksens, Karlis (author)
- Uppsala universitet,Infektionssjukdomar
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- Rombo, Lars (author)
- Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Karolinska Univ Hosp, Dept Med, Stockholm, Sweden.
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- van Rijckevorsel, Gini (author)
- Publ Hlth Serv Amsterdam, Dept Infect Dis, Amsterdam, Netherlands.
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- Richardus, Jan H. (author)
- Municipal Publ Hlth Serv Rotterdam Rijnmond, Rotterdam, Netherlands.
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- Plassmann, Georg (author)
- Unterfrintroper Hausarztzentrum, Essen, Germany.
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- Schwarz, Tino F. (author)
- Stiftung juliusspital, Cent Lab, Wurzburg, Germany.;Stiftung juliusspital, Vaccinat Ctr, Wurzburg, Germany.
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- Catteau, Gregory (author)
- GSK Vaccines, Wavre, Belgium.
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- Lal, Himal (author)
- GSK Vaccines, King Of Prussia, PA USA.
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- Heineman, Thomas C. (author)
- GSK Vaccines, King Of Prussia, PA USA.
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Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic Infektionssjukdomar (creator_code:org_t)
- Elsevier BV, 2016
- 2016
- English.
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In: Vaccine. - : Elsevier BV. - 0264-410X .- 1873-2518. ; 34:6, s. 863-868
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https://uu.diva-port... (primary) (Raw object)
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
Keyword
- Varicella-zoster virus
- Glycoprotein E
- Subunit vaccine
- lmmunogenicity
- Persistence
Publication and Content Type
- ref (subject category)
- art (subject category)
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