Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults

被引：987

作者：

Lal, Himal ^{[1
]}

Cunningham, Anthony L. ^{[2
,3
]}

Godeaux, Olivier ^{[4
]}

Chlibek, Roman ^{[5
]}

Diez-Domingo, Javier ^{[6
]}

Hwang, Shinn-Jang ^{[7
,8
]}

Levin, Myron J. ^{[9
]}

McElhaney, Janet E. ^{[10
]}

Poder, Airi ^{[11
]}

Puig-Barbera, Joan ^{[6
]}

Vesikari, Timo ^{[12
]}

Watanabe, Daisuke ^{[13
]}

Weckx, Lily ^{[14
]}

Zahaf, Toufik ^{[4
]}

Heineman, Thomas C. ^{[1
]}

机构：

[1] GSK Vaccines, King Of Prussia, PA 19406 USA

[2] Westmead Millennium Inst Med Res, Westmead, NSW, Australia

[3] Univ Sydney, Sydney, NSW 2006, Australia

[4] GSK Vaccines, Wavre, Belgium

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

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

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

[8] Natl Yang Ming Univ, Sch Med, Taipei 112, Taiwan

[9] Univ Colorado, Aurora, CO USA

[10] Adv Med Res Inst Canada, Sudbury, ON, Canada

[11] Tartu Univ Hosp, Tartu, Estonia

[12] Univ Tampere, Vaccine Res Ctr, FIN-33101 Tampere, Finland

[13] Aichi Med Univ, Dept Dermatol, Nagakute, Aichi 48011, Japan

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

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2015年 / 372卷 / 22期

关键词：

T-CELL RESPONSES; CANDIDATE VACCINE; IMMUNE-RESPONSE; VIRUS; IMMUNOGENICITY; SAFETY; ANTIGENS; QS21;

D O I：

10.1056/NEJMoa1501184

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background In previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01(B) adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. Methods We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (>= 50 years of age), stratified according to age group (50 to 59, 60 to 69, and >= 70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults. Results A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups. Conclusions The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.govnumber, NCT01165177.)

引用

页码：2087 / 2096

页数：10

共 35 条

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