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27626517 OR Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older Dotaz Zobrazit nápovědu

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Článek

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Background A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit ...

Cunningham, Anthony L
Autor Cunningham, Anthony L From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Lal, Himal
Autor Lal, Himal From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Kovac, Martina
Autor Kovac, Martina From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Chlibek, Roman
Autor Chlibek, Roman From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Hwang, Shinn-Jang
Autor Hwang, Shinn-Jang From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Díez-Domingo, Javier
Autor Díez-Domingo, Javier From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Godeaux, Olivier
Autor Godeaux, Olivier From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Levin, Myron J
Autor Levin, Myron J From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
McElhaney, Janet E
Autor McElhaney, Janet E From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)
Puig-Barberà, Joan
Autor Puig-Barberà, Joan From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia GSK Vaccines, King of Prussia, PA (H.L., T.C.H.) GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.) Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.) the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.) the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.) the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.) Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.) the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.) Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.) Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.) the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.) Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.)

The New England journal of medicine. 2016 ; 375 (11) : 1019-32.

N Engl J Med
ISSN 1533-4406
Medvik
Zdroj

Background A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). Methods This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. Results In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. Conclusions In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229 .).

Článek

Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older

Background: The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein ...

The Journal of infectious diseases. 2018 ; 217 (11) : 1750-1760. [pub] 20180505

J Infect Dis
ISSN 1537-6613
Medvik
Zdroj

Background: The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials. Methods: Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity. Results: After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups. Conclusions: Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. Clinical Trials Registration: NCT01165177; NCT01165229.

Článek

Nové možnosti očkování proti pásovému oparu
[New options for vaccination against shingles]

Herpes zoster (shingles) is a disease affecting especially the elderly. ...

Rovněž u osob ve věku ≥ 70 let dosáhla v prevenci pásového oparu vysoké účinnosti (91,3 %) ve srovnání ...

Vakcinologie. 2018 ; 12 (2) : 64-69.

Vakcinologie (Praha)
ISSN 1802-3150
Medvik
Zdroj

Pásový opar je onemocnění postihující zejména starší osoby. Hranicí, kdy začíná nárůst incidence onemocnění, je věk 50 let. V nejvyšším riziku onemocnění jsou nejstarší věkové kategorie. Druhým základním rizikovým faktorem pro vznik pásového oparu je imunosuprese jakékoli etiologie. V roce 2017 byla registrovaná nová neživá subjednotková rekombinantní adjuvovaná herpetická vakcína Shingrix, která tak doplnila živou oslabenou vakcínu Zostavax registrovanou již v roce 2006. Nová vakcína prokázala vysoku účinnost (97,2 %) v prevenci pásového oparu u osob ve věku ≥ 50 let. Rovněž u osob ve věku ≥ 70 let dosáhla v prevenci pásového oparu vysoké účinnosti (91,3 %) ve srovnání s živou oslabenou vakcínou (37,9 %). Vzhledem k předpokládanému nárůstu incidence pásového oparu ve vztahu ke stárnutí populace je registrace nové vysoce účinné vakcíny nepochybně významným benefitem. Nepříjemnou, i když do jisté míry očekávanou, stránkou aktuální situace je však reálná dostupnost nové očkovací látky. Vakcína, i když registrovaná v rámci Evropské unie, není v současnosti na trhu v České republice dostupná.

Herpes zoster (shingles) is a disease affecting especially the elderly. Increase in the incidence of the disease begins at the age of 50 years. At the highest risk of shingles are the oldest age categories. The second primary risk factor for shingles is immunosuppression of any etiology. A new subunit recombinant adjuvanted herpes zoster vaccine (Shingrix) was registered in 2017 to supplement the live attenuated vaccine (Zostavax) already registered in 2006. High vaccine efficacy against herpes zoster (97.2 %) was confirmed in adults 50 years of age or older. Simultaneously, the vaccine efficacy against herpes zoster (91.3 %) in adults 70 years of age or older was higher than vaccine efficacy of live attenuated vaccine (37.9 %). Given the projected increase in the incidence of shingles in relation to population aging, the registration of a new highly effective vaccine is a significant benefit. However, the real availability of the new vaccine on the market is questionable. The vaccine, although registered in the European Union, is currently not available in the Czech Republic.

Klíčová slova
Shingrix,
MeSH
antivirové látky terapeutické užití MeSH
dospělí MeSH
herpes zoster epidemiologie etiologie farmakoterapie patofyziologie prevence a kontrola MeSH
imunosupresivní léčba škodlivé účinky MeSH
klinická studie jako téma MeSH
lidé středního věku MeSH
lidé MeSH
postherpetická neuralgie farmakoterapie prevence a kontrola MeSH
senioři MeSH
vakcína proti pásovému oparu * aplikace a dávkování MeSH
Check Tag
dospělí MeSH
lidé středního věku MeSH
lidé MeSH
senioři MeSH
Publikační typ
práce podpořená grantem MeSH
přehledy MeSH

Kolekce

Publikováno

Filtry

27626517 OR Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older Dotaz Zobrazit nápovědu

27626517 OR Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older Dotaz Zobrazit nápovědu

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