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Safety and immunoge...
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
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Chlibek, Roman (författare)
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Smetana, Jan (författare)
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- Pauksens, Karlis (författare)
- Uppsala universitet,Infektionssjukdomar
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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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(creator_code:org_t)
- Elsevier BV, 2014
- 2014
- Engelska.
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X .- 1873-2518. ; 32:15, s. 1745-1753
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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).
Nyckelord
- Varicella-zoster virus
- Herpes zoster
- Vaccine
- Adjuvant
- gE
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Vaccine
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- Av författaren/redakt...
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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...
- Artiklar i publikationen
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Vaccine
- Av lärosätet
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Uppsala universitet