Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

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

R. Chlibek, J. Smetana, K. Pauksens, L. Rombo, JA. Van den Hoek, JH. Richardus, G. Plassmann, TF. Schwarz, E. Ledent, TC. Heineman,

. 2014 ; 32 (15) : 1745-53.

Jazyk angličtina Země Nizozemsko

Typ dokumentu klinické zkoušky, fáze II, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc14074287
E-zdroje Online Plný text

NLK ProQuest Central od 2002-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest) od 2002-01-01 do Před 2 měsíci
Health & Medicine (ProQuest) od 2002-01-01 do Před 2 měsíci
Family Health Database (ProQuest) od 2002-01-01 do Před 2 měsíci
Health Management Database (ProQuest) od 2002-01-01 do Před 2 měsíci
Public Health Database (ProQuest) od 2002-01-01 do Před 2 měsíci

Odkazy

PubMed 24508036
DOI 10.1016/j.vaccine.2014.01.019
Knihovny.cz E-zdroje

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 AS01B. METHODS: In this phase II, single-blind, randomized, controlled study, adults aged ≥60years (N=714) received one dose of 100μggE/AS01B, two doses, two months apart, of 25, 50, or 100μggE/AS01B, or two doses of unadjuvanted 100μggE/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/AS01B formulations than after one dose of 100μggE/AS01B or two doses of 100μggE/saline. Frequencies were comparable after two doses of 25, 50, or 100μggE/AS01B. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100μggE/AS01B and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01B formulations were similar but greater than with gE/saline. CONCLUSIONS: The three formulations of gE/AS01B were immunogenic and well tolerated in adults aged ≥60years. Two vaccinations with gE/AS01B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc14074287
003      
CZ-PrNML
005      
20141008110228.0
007      
ta
008      
141006s2014 ne f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.vaccine.2014.01.019 $2 doi
035    __
$a (PubMed)24508036
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ne
100    1_
$a Chlibek, Roman $u Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.
245    10
$a 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 / $c R. Chlibek, J. Smetana, K. Pauksens, L. Rombo, JA. Van den Hoek, JH. Richardus, G. Plassmann, TF. Schwarz, E. Ledent, TC. Heineman,
520    9_
$a 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 AS01B. METHODS: In this phase II, single-blind, randomized, controlled study, adults aged ≥60years (N=714) received one dose of 100μggE/AS01B, two doses, two months apart, of 25, 50, or 100μggE/AS01B, or two doses of unadjuvanted 100μggE/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/AS01B formulations than after one dose of 100μggE/AS01B or two doses of 100μggE/saline. Frequencies were comparable after two doses of 25, 50, or 100μggE/AS01B. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100μggE/AS01B and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01B formulations were similar but greater than with gE/saline. CONCLUSIONS: The three formulations of gE/AS01B were immunogenic and well tolerated in adults aged ≥60years. Two vaccinations with gE/AS01B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).
650    _2
$a adjuvancia imunologická $x aplikace a dávkování $7 D000276
650    _2
$a senioři $7 D000368
650    _2
$a protilátky virové $x krev $7 D000914
650    _2
$a CD4-pozitivní T-lymfocyty $x imunologie $7 D015496
650    _2
$a imunologická odpověď na dávku $7 D004306
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a vakcína proti pásovému oparu $x škodlivé účinky $x imunologie $x terapeutické užití $7 D053061
650    _2
$a lidé $7 D006801
650    12
$a buněčná imunita $7 D007111
650    12
$a humorální imunita $7 D056724
650    _2
$a očkovací schéma $7 D007115
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a jednoduchá slepá metoda $7 D016037
650    _2
$a subjednotkové vakcíny $x škodlivé účinky $x imunologie $x terapeutické užití $7 D022223
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Smetana, Jan $u Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic. Electronic address: smetana@pmfhk.cz.
700    1_
$a Pauksens, Karlis $u Department of Medical Science, Section of Infectious Diseases, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden.
700    1_
$a Rombo, Lars $u Clinical Research Center, Sormland County Council, Eskilstuna, Sweden; Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.
700    1_
$a Van den Hoek, J Anneke R $u Public Health Service Amsterdam, The Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Centre, Amsterdam, The Netherlands.
700    1_
$a Richardus, Jan H $u Municipal Public Health Service Rotterdam-Rijnmond, Rotterdam, The Netherlands.
700    1_
$a Plassmann, Georg $u Unterfrintroper Hausarztzentrum, Essen, Germany.
700    1_
$a Schwarz, Tino F $u Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany.
700    1_
$a Ledent, Edouard $u GlaxoSmithKline Vaccines, Wavre, Belgium.
700    1_
$a Heineman, Thomas C $u GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
773    0_
$w MED00004631 $t Vaccine $x 1873-2518 $g Roč. 32, č. 15 (2014), s. 1745-53
856    41
$u https://pubmed.ncbi.nlm.nih.gov/24508036 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20141006 $b ABA008
991    __
$a 20141008110616 $b ABA008
999    __
$a ok $b bmc $g 1042170 $s 873199
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2014 $b 32 $c 15 $d 1745-53 $i 1873-2518 $m Vaccine $n Vaccine $x MED00004631
LZP    __
$a Pubmed-20141006

Najít záznam

Citační ukazatele

Možnosti archivace