Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine

被引：43

作者：

Grupping, Katrijn ^{[1
]}

Campora, Laura ^{[1
]}

Douha, Martine ^{[1
]}

Heineman, Thomas C. ^{[2
]}

Klein, Nicola P. ^{[3
]}

Lal, Himal ^{[4
]}

Peterson, James ^{[5
]}

Vastiau, Ilse ^{[1
]}

Oostvogels, Lidia ^{[1
]}

机构：

[1] GSK Vaccine, Wavre, Belgium

[2] Genocea Biosci, Cambridge, MA USA

[3] Kaiser Permanente Vaccine Study Ctr, Oakland, CA USA

[4] Pfizer Inc, Collegeville, PA USA

[5] Foothill Family Clin, Salt Lake City, UT USA

来源：

JOURNAL OF INFECTIOUS DISEASES | 2017年 / 216卷 / 11期

关键词：

herpes zoster; HZ/su adjuvanted herpes zoster subunit vaccine; live attenuated zoster vaccine Zostavax; immune response; revaccination; CANDIDATE VACCINE; POSTHERPETIC NEURALGIA; TERM PERSISTENCE; VARICELLA; EFFICACY; PATHOGENESIS; POPULATION; PREVENTION; IMMUNITY; RATES;

D O I：

10.1093/infdis/jix482

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background. Protection against herpes zoster (HZ) induced by the live attenuated zoster vaccine Zostavax (ZVL) wanes within 3-7 years. Revaccination may renew protection. We assessed whether (re) vaccination with the adjuvanted HZ subunit vaccine candidate (HZ/su) induced comparable immune responses in previous ZVL recipients and ZVL-naive individuals (HZ-NonVac). Methods. In an open-label, multicenter study, adults >= 65 years of age, vaccinated with ZVL >= 5 years previously (HZ-PreVac), were matched to ZVL-naive adults (HZ-NonVac). Participants received 2 doses of HZ/su 2 months apart. The primary objective of noninferiority of the humoral immune response 1 month post-dose 2 was considered demonstrated if the upper limit of the 95% confidence interval (CI) of the adjusted anti-glycoprotein E geometric mean concentration (GMC) ratio of HZ-NonVac over HZ-PreVac was <1.5. HZ/su cellular immunogenicity, reactogenicity, and safety were also assessed. Results. In 430 participants, humoral immune response to HZ/su was noninferior in HZ-PreVac compared with HZ-NonVac (adjusted GMC ratio, 1.04 [95% CI,.92-1.17]). Cellular immunogenicity, reactogenicity, and safety appeared to be comparable between groups. HZ/su was well-tolerated, with no safety concerns raised within 1 month post-dose 2. Conclusions. HZ/su induces a strong immune response irrespective of prior vaccination with ZVL, and may be an attractive option to revaccinate prior ZVL recipients.

引用

页码：1343 / 1351

页数：9

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