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

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

Cunningham, A. L. (författare): Westmead Inst Med Res, Westmead, NSW, Australia.;Univ Sydney, Sydney, NSW, Australia.

Lal, H. (författare): GSK Vaccines, King Of Prussia, PA USA.

Kovac, M. (författare): GSK Vaccines, Wavre, Belgium.

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Chlibek, R. (författare): Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.

Hwang, S. -J (författare)

Diez-Domingo, J. (författare): Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.

Godeaux, O. (författare): GSK Vaccines, Wavre, Belgium.

Levin, M. J. (författare): Univ Colorado, Dept Pediat, Anschutz Med Campus, Aurora, CO USA.;Univ Colorado, Dept Med, Anschutz Med Campus, Aurora, CO USA.

McElhaney, J. E. (författare): Hlth Sci North Res Inst, Sudbury, ON, Canada.

Puig-Barbera, J. (författare): Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.

Abeele, C. Vanden (författare): GSK Vaccines, Wavre, Belgium.

Vesikari, T. (författare): Univ Tampere, Vaccine Res Ctr, Tampere, Finland.

Watanabe, D. (författare): Aichi Med Univ, Dept Dermatol, Nagakute, Aichi, Japan.

Zahaf, T. (författare): GSK Vaccines, Wavre, Belgium.

Ahonen, A. (författare): Univ Tampere, Vaccine Res Ctr, Tampere, Finland.

Athan, E. (författare): Deakin Univ, Barwon Hlth, Dept Infect Dis, Geelong, Vic, Australia.

Barba-Gomez, J. F. (författare): Inst Dermatol Jalisco Dr Jose Barba Rubio, Zapopan, Mexico.

Campora, L. (författare): GSK Vaccines, Wavre, Belgium.

de Looze, F. (författare): Univ Queensland, Sch Med, AusTrials, Brisbane, Qld, Australia.;Univ Queensland, Sch Med, Discipline Gen Practice, Brisbane, Qld, Australia.

Downey, H. J. (författare): Jacksonville Ctr Clin Res, Jacksonville, FL USA.

Ghesquiere, W. (författare): Univ British Columbia, Infect Dis Sect, Victoria, BC, Canada.

Gorfinkel, I. (författare): PrimeHlth Clin Res, Toronto, ON, Canada.

Korhonen, T. (författare): Univ Tampere, Vaccine Res Ctr, Tampere, Finland.

Leung, E. (författare): United Christian Hosp, Dept Med & Geriatr, Div Geriatr Med, Hong Kong, Hong Kong, Peoples R China.

McNeil, S. A. (författare): Dalhousie Univ, IWK Hlth Ctr, Canadian Ctr Vaccinol, Halifax, NS, Canada.;Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada.

Oostvogels, L. (författare): GSK Vaccines, Wavre, Belgium.

Rombo, Lars (författare): Uppsala universitet,Medicinska fakulteten,Centrum för klinisk forskning i Sörmland (CKFD),Sormland Cty Council, Clin Res Ctr, Eskilstuna, Sweden.

Smetana, J. (författare): Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.

Weckx, L. (författare): Univ Fed Sao Paulo, Ctr Referencia Imunobiol Especiais, Sao Paulo, Brazil.

Yeo, W. (författare): Univ Wollongong, Grad Sch Med, Illawarra Hlth & Med Res Inst, Wollongong, NSW, Australia.

Heineman, T. C. (författare): GSK Vaccines, King Of Prussia, PA USA.

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Westmead Inst Med Res, Westmead, NSW, Australia;Univ Sydney, Sydney, NSW, Australia. GSK Vaccines, King Of Prussia, PA USA. (creator_code:org_t)

2016
2016
Engelska.
Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 375:11, s. 1019-1032

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

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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 AS01(B) 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.govnumbers, NCT01165177 and NCT01165229.)

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

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