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

被引：681

作者：

Cunningham, A. L. ^{[1
,2
]}

Lal, H. ^{[7
]}

Kovac, M. ^{[8
]}

Chlibek, R. ^{[9
]}

Hwang, S. -J. ^{[10
,11
]}

Diez-Domingo, J. ^{[12
]}

Godeaux, O. ^{[8
]}

Levin, M. J. ^{[13
,14
]}

McElhaney, J. E. ^{[15
]}

Puig-Barbera, J. ^{[12
]}

Abeele, C. Vanden ^{[8
]}

Vesikari, T. ^{[20
]}

Watanabe, D. ^{[21
]}

Zahaf, T. ^{[8
]}

Ahonen, A. ^{[20
]}

Athan, E. ^{[3
]}

Barba-Gomez, J. F. ^{[22
]}

Campora, L. ^{[8
]}

de Looze, F. ^{[4
,5
]}

Downey, H. J. ^{[23
]}

Ghesquiere, W. ^{[16
]}

Gorfinkel, I. ^{[17
]}

Korhonen, T. ^{[20
]}

Leung, E. ^{[24
]}

McNeil, S. A. ^{[18
,19
]}

Oostvogels, L. ^{[8
]}

Rombo, L. ^{[25
,26
]}

Smetana, J. ^{[9
]}

Weckx, L. ^{[27
]}

Yeo, W. ^{[6
]}

Heineman, T. C. ^{[7
]}

机构：

[1] Westmead Inst Med Res, Westmead, NSW, Australia

[2] Univ Sydney, Sydney, NSW, Australia

[3] Deakin Univ, Barwon Hlth, Dept Infect Dis, Geelong, Vic, Australia

[4] Univ Queensland, Sch Med, AusTrials, Brisbane, Qld, Australia

[5] Univ Queensland, Sch Med, Discipline Gen Practice, Brisbane, Qld, Australia

[6] Univ Wollongong, Grad Sch Med, Illawarra Hlth & Med Res Inst, Wollongong, NSW, Australia

[7] GSK Vaccines, King Of Prussia, PA USA

[8] GSK Vaccines, Wavre, Belgium

[9] Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic

[10] Taipei Vet Gen Hosp, Dept Family Med, Taipei, Taiwan

[11] Natl Yang Ming Univ, Sch Med, Taipei, Taiwan

[12] Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain

[13] Univ Colorado, Dept Pediat, Anschutz Med Campus, Aurora, CO USA

[14] Univ Colorado, Dept Med, Anschutz Med Campus, Aurora, CO USA

[15] Hlth Sci North Res Inst, Sudbury, ON, Canada

[16] Univ British Columbia, Infect Dis Sect, Victoria, BC, Canada

[17] PrimeHlth Clin Res, Toronto, ON, Canada

[18] Dalhousie Univ, IWK Hlth Ctr, Canadian Ctr Vaccinol, Halifax, NS, Canada

[19] Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada

[20] Univ Tampere, Vaccine Res Ctr, Tampere, Finland

[21] Aichi Med Univ, Dept Dermatol, Nagakute, Aichi, Japan

[22] Inst Dermatol Jalisco Dr Jose Barba Rubio, Zapopan, Mexico

[23] Jacksonville Ctr Clin Res, Jacksonville, FL USA

[24] United Christian Hosp, Dept Med & Geriatr, Div Geriatr Med, Hong Kong, Hong Kong, Peoples R China

[25] Sormland Cty Council, Clin Res Ctr, Eskilstuna, Sweden

[26] Uppsala Univ, Uppsala, Sweden

[27] Univ Fed Sao Paulo, Ctr Referencia Imunobiol Especiais, Sao Paulo, Brazil

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2016年 / 375卷 / 11期

关键词：

POSTHERPETIC NEURALGIA; CANDIDATE VACCINE; VIRUS; PHASE; IMMUNOGENICITY; MANAGEMENT; SAFETY; POPULATION; BURDEN; RATES;

D O I：

10.1056/NEJMoa1603800

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：1019 / 1032

页数：14

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