-
Something wrong with this record ?
Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials
L. Oostvogels, TC. Heineman, RW. Johnson, MJ. Levin, JE. McElhaney, P. Van den Steen, T. Zahaf, AF. Dagnew, R. Chlibek, J. Diez-Domingo, IS. Gorfinkel, C. Hervé, SJ. Hwang, H. Ikematsu, G. Kalema, H. Lal, SA. McNeil, T. Mrkvan, K. Pauksens, J....
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 2012 to 1 year ago
PubMed Central
from 2012 to 1 year ago
Europe PubMed Central
from 2012 to 1 year ago
- MeSH
- Adjuvants, Immunologic administration & dosage MeSH
- Chronic Disease MeSH
- Herpes Zoster prevention & control MeSH
- Immunocompromised Host MeSH
- Data Interpretation, Statistical MeSH
- Comorbidity MeSH
- Middle Aged MeSH
- Humans MeSH
- Neuralgia, Postherpetic immunology prevention & control MeSH
- Vaccine Potency * MeSH
- Risk Factors MeSH
- Aged MeSH
- Vaccines, Synthetic immunology MeSH
- Herpes Zoster Vaccine administration & dosage immunology MeSH
- Vaccination MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.
Department of Dermatology Aichi Medical University Nagakute Japan
Department of Infectious Diseases Uppsala University Hospital Uppsala Sweden
Department of Pediatrics Federal University of Sao Paulo Sao Paulo Brazil
Departments of Pediatrics and Medicine University of Colorado Anschutz Medical Campus Aurora CO USA
Faculty of Health Sciences University of Bristol Bristol UK
Faculty of Military Health Sciences University of Defense Hradec Kralove Czech Republic
Fundación para el Fomento de la Investigación Sanitaria y Biomédica Valencia Spain
Health Sciences North Research Institute Sudbury Ontario Canada
Japan Physicians Association Tokyo Japan
Keyrus Biopharma Waterloo Belgium on behalf of GSK
PrimeHealth Clinical Research Toronto Ontario Canada
The Westmead Institute for Medical Research Westmead University of Sydney Sydney NSW Australia
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc20022941
- 003
- CZ-PrNML
- 005
- 20201214125014.0
- 007
- ta
- 008
- 201125s2019 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1080/21645515.2019.1627818 $2 doi
- 035 __
- $a (PubMed)31216205
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Oostvogels, Lidia $u GSK, Wavre, Belgium.
- 245 10
- $a Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials / $c L. Oostvogels, TC. Heineman, RW. Johnson, MJ. Levin, JE. McElhaney, P. Van den Steen, T. Zahaf, AF. Dagnew, R. Chlibek, J. Diez-Domingo, IS. Gorfinkel, C. Hervé, SJ. Hwang, H. Ikematsu, G. Kalema, H. Lal, SA. McNeil, T. Mrkvan, K. Pauksens, J. Smetana, D. Watanabe, LY. Weckx, AL. Cunningham,
- 520 9_
- $a In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.
- 650 _2
- $a adjuvancia imunologická $x aplikace a dávkování $7 D000276
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a chronická nemoc $7 D002908
- 650 _2
- $a komorbidita $7 D015897
- 650 _2
- $a interpretace statistických dat $7 D003627
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a herpes zoster $x prevence a kontrola $7 D006562
- 650 _2
- $a vakcína proti pásovému oparu $x aplikace a dávkování $x imunologie $7 D053061
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a imunokompromitovaný pacient $7 D016867
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a postherpetická neuralgie $x imunologie $x prevence a kontrola $7 D051474
- 650 _2
- $a rizikové faktory $7 D012307
- 650 _2
- $a vakcinace $7 D014611
- 650 12
- $a potence vakcíny $7 D064166
- 650 _2
- $a syntetické vakcíny $x imunologie $7 D014614
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 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 Heineman, Thomas C $u GSK, King of Prussia, PA, USA.
- 700 1_
- $a Johnson, Robert W $u Faculty of Health Sciences, University of Bristol, Bristol, UK.
- 700 1_
- $a Levin, Myron J $u Departments of Pediatrics and Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
- 700 1_
- $a McElhaney, Janet E $u Health Sciences North Research Institute, Sudbury, Ontario, Canada.
- 700 1_
- $a Van den Steen, Peter $u GSK, Wavre, Belgium.
- 700 1_
- $a Zahaf, Toufik $u GSK, Wavre, Belgium.
- 700 1_
- $a Dagnew, Alemnew F $u GSK, Rockville, MD, USA.
- 700 1_
- $a Chlibek, Roman $u Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
- 700 1_
- $a Diez-Domingo, Javier $u Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain.
- 700 1_
- $a Gorfinkel, Iris S $u PrimeHealth Clinical Research, Toronto, Ontario, Canada.
- 700 1_
- $a Hervé, Caroline $u GSK, Wavre, Belgium.
- 700 1_
- $a Hwang, Shinn-Jang $u Department of Family Medicine, Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taipei, Taiwan.
- 700 1_
- $a Ikematsu, Hideyuki $u Japan Physicians Association, Tokyo, Japan.
- 700 1_
- $a Kalema, George $u Keyrus Biopharma, Waterloo, Belgium, on behalf of GSK.
- 700 1_
- $a Lal, Himal $u GSK, King of Prussia, PA, USA.
- 700 1_
- $a McNeil, Shelly A $u Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie, University, Halifax, Canada.
- 700 1_
- $a Mrkvan, Tomas $u GSK, Wavre, Belgium.
- 700 1_
- $a Pauksens, Karlis $u Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.
- 700 1_
- $a Smetana, Jan $u Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
- 700 1_
- $a Watanabe, Daisuke $u Department of Dermatology, Aichi Medical University, Nagakute, Japan.
- 700 1_
- $a Weckx, Lily Yin $u Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.
- 700 1_
- $a Cunningham, Anthony L $u The Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, NSW, Australia.
- 773 0_
- $w MED00181409 $t Human vaccines & immunotherapeutics $x 2164-554X $g Roč. 15, č. 12 (2019), s. 2865-2872
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/31216205 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20201125 $b ABA008
- 991 __
- $a 20201214125013 $b ABA008
- 999 __
- $a ok $b bmc $g 1595260 $s 1113617
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2019 $b 15 $c 12 $d 2865-2872 $e 20190628 $i 2164-554X $m Human vaccines & immunotherapeutics $n Hum Vaccin Immunother $x MED00181409
- LZP __
- $a Pubmed-20201125
