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

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.

SUBMITTER: Grupping K

PROVIDER: S-EPMC5853346 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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

Grupping Katrijn K Campora Laura L Douha Martine M Heineman Thomas C TC Klein Nicola P NP Lal Himal H Peterson James J Vastiau Ilse I Oostvogels Lidia L

The Journal of infectious diseases 20171201 11

<h4>Background</h4>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).<h4>Methods</h4>In an open-label, multicenter study, adults ≥65 years of age, vaccinated with ZVL ≥5 years previously (HZ-PreVac ...[more]

PMID: 29029122

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Project description:Abstract Background For the first time, we present data describing vaccine efficacy (VE), immunogenicity persistence and safety up to approximately 10 years after primary vaccination against HZ with RZV. We have previously shown that RZV demonstrated high VE against HZ in adults ≥ 50 years of age (YOA) participating in 2 phase 3 clinical trials (ZOE-50, NCT01165177 and ZOE-70, NCT01165229), and VE persisted up to year (Y) 2 in the interim analysis of the extension study (ZOSTER-049, NCT02723773). Here we describe the interim analysis for Y4 of the extension study. Understanding the persistence of VE and long-term protection against HZ can help to optimize the use of RZV in adults ≥ 50 YOA. Methods The study design is detailed in Figure 1. Primary objective included VE against HZ over the ZOSTER-049 study. Secondary objectives included VE against HZ from 1 month post-dose 2 in the ZOE-50/-70 studies until the end of Y4 of ZOSTER-049 (Y10 after vaccination), persistence of vaccine-induced humoral immunogenicity (HI) in terms of anti-glycoprotein E (gE) antibody and cell-mediated immune (CMI) response in terms of frequency of gE-specific CD4[2+] T-cells and safety. VE analysis for ZOSTER-049 used historical control estimates from the ZOE-50/-70 placebo groups. Results In ZOSTER-049, 7,413 participants were enrolled and 7,277 were included in VE analysis (Figure 2). During 4 years of follow-up in ZOSTER-049, overall VE against HZ was 81.6% (95% confidence interval [CI]: 75.2–86.6). From 1 month post-dose 2 in ZOE-50/-70 until Y4 of ZOSTER-049, the overall VE was 89.0% (95% CI: 85.6–91.3). In ZOSTER-049, anti-gE antibody concentrations persisted > 5 times above pre-vaccination up to Y10 after vaccination (Figure 3A). The frequency of gE-specific CD4[2+] T-cells remained above pre-vaccination from Y6 to Y10 after vaccination (until the end of Y4 of ZOSTER-049) (Figure 3B). No safety signals were identified until the end of Y4 of ZOSTER-049. Conclusion Efficacy against HZ and immune responses to RZV remained high until the end of the observation period for this Y4 interim analysis suggesting that the clinical benefit of the RZV in adults ≥ 50 YOA is sustained for at least 10 years after vaccination. RZV safety profile remained clinically acceptable. Funding GlaxoSmithKline Biologicals SA Disclosures Ana Strezova, MD, MSc, GSK: I am an employee of GSK group of companies and hold shares from GSK group of companies as part of my employee remuneration Javier Diez-Domingo, MD, PhD, GSK: Grant/Research Support|GSK: Honoraria|MSD: Advisor/Consultant|MSD: Grant/Research Support|MSD: Consulting fees to the author and his institution|SANOFI: Advisor/Consultant|SANOFI: Grant/Research Support|SANOFI PASTEUR: Consulting fees to the author and his institution|SEQIRUS: Honoraria|SEQIRUS: Honoraria to the author and his institution Kamal Al Shawafi, MD, Modis: I am an employee of Modis, working on behalf of the GSK group of companies Juan Carlos Tinoco, MD, GSK: Grant/Research Support Meng Shi, MS, GSK: I am an employee of GSK group of companies Paola Pirrotta, n/a, GSK: I am an employee of GSK group of companies and hold shares from GSK group of companies as part of my employee remuneration Agnes Mwakingwe-Omari, MD/PhD, GSK: I am an employee of GSK group of companies.

Dataset Information

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

Publications

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

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