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  • Chlibek, RomanUniv Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic. (författare)

Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults

  • Artikel/kapitelEngelska2016

Förlag, utgivningsår, omfång ...

  • Elsevier BV,2016
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-280259
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-280259URI
  • https://doi.org/10.1016/j.vaccine.2015.09.073DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Pauksens, KarlisUppsala universitet,Infektionssjukdomar(Swepub:uu)karlpauk (författare)
  • Rombo, LarsUppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Karolinska Univ Hosp, Dept Med, Stockholm, Sweden.(Swepub:uu)larra728 (författare)
  • van Rijckevorsel, GiniPubl Hlth Serv Amsterdam, Dept Infect Dis, Amsterdam, Netherlands. (författare)
  • Richardus, Jan H.Municipal Publ Hlth Serv Rotterdam Rijnmond, Rotterdam, Netherlands. (författare)
  • Plassmann, GeorgUnterfrintroper Hausarztzentrum, Essen, Germany. (författare)
  • Schwarz, Tino F.Stiftung juliusspital, Cent Lab, Wurzburg, Germany.;Stiftung juliusspital, Vaccinat Ctr, Wurzburg, Germany. (författare)
  • Catteau, GregoryGSK Vaccines, Wavre, Belgium. (författare)
  • Lal, HimalGSK Vaccines, King Of Prussia, PA USA. (författare)
  • Heineman, Thomas C.GSK Vaccines, King Of Prussia, PA USA. (författare)
  • Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.Infektionssjukdomar (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Vaccine: Elsevier BV34:6, s. 863-8680264-410X1873-2518

Internetlänk

Hitta via bibliotek

  • Vaccine (Sök värdpublikationen i LIBRIS)

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