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Safety and immunoge...
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Chlibek, Roman
(författare)
Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults : A phase II, randomized, controlled study
- Artikel/kapitelEngelska2014
Förlag, utgivningsår, omfång ...
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Elsevier BV,2014
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-224365
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-224365URI
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https://doi.org/10.1016/j.vaccine.2014.01.019DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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Background: This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E (gE) with or without the adjuvant system ASO1(B). Methods: In this phase II, single-blind, randomized, controlled study, adults aged >= 60 years (N = 714) received one dose of 100 mu g gE/AS01(B), two doses, two months apart, of 25, 50, or 100 mu g gE/AS01(B), or two doses of unadjuvanted 100 mu g gE/saline. Frequencies of CD4(+) T cells expressing >= 2 activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA. Results: Frequencies of gE-specific CD4(+) T cells were >3-fold higher after two doses of all gE/AS01(B) formulations than after one dose of 100 mu g gE/AS01(B) or two doses of 100 mu g gE/saline. Frequencies were comparable after two doses of 25, 50, or 100 mu g gE/AS01g. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100 mu g gE/AS01(B) and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01(B) formulations were similar but greater than with gE/saline. Conclusions: The three formulations of gE/AS01(B) were immunogenic and well tolerated in adults aged >= 60 years. Two vaccinations with gE/AS01(B) induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).
Ämnesord och genrebeteckningar
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Varicella-zoster virus
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Herpes zoster
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Vaccine
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Adjuvant
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gE
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Smetana, Jan
(författare)
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Pauksens, KarlisUppsala universitet,Infektionssjukdomar(Swepub:uu)karlpauk
(författare)
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Rombo, Lars
(författare)
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Van den Hoek, J. Anneke R.
(författare)
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Richardus, Jan H.
(författare)
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Plassmann, Georg
(författare)
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Schwarz, Tino F.
(författare)
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Ledent, Edouard
(författare)
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Heineman, Thomas C.
(författare)
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Uppsala universitetInfektionssjukdomar
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Vaccine: Elsevier BV32:15, s. 1745-17530264-410X1873-2518
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Vaccine
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Chlibek, Roman
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Smetana, Jan
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Pauksens, Karlis
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Rombo, Lars
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Van den Hoek, J. ...
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Richardus, Jan H ...
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visa fler...
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Plassmann, Georg
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Schwarz, Tino F.
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Ledent, Edouard
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Heineman, Thomas ...
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visa färre...
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Vaccine
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Uppsala universitet