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.
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收藏
页码：1343 / 1351
页数：9
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