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J Infect Dis. 2017 Dec 12;216(11):1343-1351. doi: 10.1093/infdis/jix482.

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

Author information

1
GSK Vaccine, Wavre, Belgium.
2
Genocea Biosciences, Cambridge, Massachusetts.
3
Kaiser Permanente Vaccine Study Center, Oakland, California.
4
Pfizer Inc, Collegeville, Pennsylvania.
5
Foothill Family Clinic, Salt Lake City, Utah.

Abstract

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.

Clinical Trials Registration:

NCT02581410.

KEYWORDS:

HZ/su adjuvanted herpes zoster subunit vaccine; herpes zoster; immune response; live attenuated zoster vaccine Zostavax; revaccination

PMID:
29029122
PMCID:
PMC5853346
DOI:
10.1093/infdis/jix482
[Indexed for MEDLINE]
Free PMC Article

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