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

被引：679

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

共 50 条

[41] Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial
Godeaux, Olivier
Kovac, Martina
Shu, Daniel
Grupping, Katrijn
Campora, Laura
Douha, Martine
Heineman, Thomas C.
Lal, Himal
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2017, 13 (05) : 1051 - 1058
[42] Zoster Vaccine (Zostavax®) A Review of its Use in Preventing Herpes Zoster and Postherpetic Neuralgia in Older Adults
Sanford, Mark
Keating, Gillian M.
DRUGS & AGING, 2010, 27 (02) : 159 - 176
[43] Varicella-Zoster virus vaccine: A review of its use in the prevention of herpes zoster in older adults
Caple, Jane
DRUGS OF TODAY, 2006, 42 (04) : 249 - 254
[44] Zoster Vaccine (Zostavax®)A Review of its Use in Preventing Herpes Zoster and Postherpetic Neuralgia in Older Adults
Mark Sanford
Gillian M. Keating
Drugs & Aging, 2010, 27 : 159 - 176
[45] Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older
De Villiers, Pierre J. T.
Steele, A. Duncan
Hiemstra, Louis A.
Rappaport, Ruth
Dunning, Andrew J.
Gruber, William C.
Forrest, Bruce D.
VACCINE, 2009, 28 (01) : 228 - 234
[46] Efficacy of herpes zoster vaccine decreases with time
Reactions Weekly, 2015, 1547 (1) : 8 - 8
[47] Optimal gender-specific age for cost-effective vaccination with adjuvanted herpes zoster subunit vaccine in Chinese adults
You, Joyce H. S.
Ming, Wai-kit
Tsang, Owen Tak-yin
Chan, Paul Kay-sheung
PLOS ONE, 2019, 14 (01):
[48] Safety and Immunogenicity of an AS01-adjuvanted Varicella-zoster Virus Subunit Candidate Vaccine Against Herpes Zoster in Adults ≥50 Years of Age (vol 208, pg 1953, 2013)
Chlibek, Roman
Bayas, Jose M.
Collins, Harry
de la Pinta, Maria Luisa Rodriguez
Ledent, Edouard
Mols, Johann F.
Heineman, Thomas C.
JOURNAL OF INFECTIOUS DISEASES, 2021, 223 (02): : 353 - 353
[49] A vaccine to prevent herpes zoster and post-herpetic neuralgia in older adults.
Jubelt B.
Current Neurology and Neuroscience Reports, 2005, 5 (6) : 427 - 428
[50] Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults
Hornberger, John
Robertus, Katherine
ANNALS OF INTERNAL MEDICINE, 2006, 145 (05) : 317 - 325

← 1 2 3 4 5 →