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ORIGINAL ARTICLE
Efficacy, Safety and Immunogenicity of a Novel Adjuvanted Subunit Herpes Zoster Vaccine in Japanese Aged 50 Years and 70 Years and Older
1)Japan Physicians Association, 2)Japan Vaccine Co. Ltd., 3)GlaxoSmithKline, USA, 4)Department of Dermatology, Aichi Medical University
Hideyuki IKEMATSU1), Nobuyuki YAMASHITA2), Masayuki OGAWA2), Motonori HIRANO2), Martina KOVAC3) & Daisuke WATANABE4)
(Received July 3, 2017)
(Accepted November 7, 2017)
Key words: herpes zoster vaccine, Japanese, adjuvant, vaccine efficacy, safety
Abstract

Two large randomized multinational efficacy trials (ZOE-50 and ZOE-70) showed that the novel herpes zoster subunit vaccine (HZ/su) candidate containing varicella-zoster virus glycoprotein E (gE) and the AS01B adjuvant system reduced the risk of herpes zoster (HZ) and post-herpetic neuralgia (PHN) by more than 90%. We conducted a descriptive subgroup analysis in subjects enrolled in Japan in these studies and evaluated the results.

Participants received two doses of HZ/su or a placebo (assigned in a 1: 1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against HZ was assessed in participants aged ≥50 years in ZOE-50 and in a pooled analyses of participants aged ≥70 years from ZOE-70 and ZOE-50. Vaccine efficacy against PHN was also assessed as a co-primary endpoint. Safety was assessed in all subjects and reactogenicity was assessed in a subgroup of participants. Humoral and cell mediated immunogenicity (CMI) were assessed in the respective subset for which blood samples were collected.

A total of 577 participants from ZOE-50 and 511 participants from ZOE-70 were enrolled in Japan, with a total of 1,042 included in the efficacy analysis (561 and 481 subjects, respectively). Overall vaccine efficacy against HZ in 561 adults ≥50 years was 81.4% (95% confidence interval [CI]: 14.9-98.0%). In the pooled analysis of all Japanese ZOE-50 and ZOE-70 participants ≥70 years (N=608), vaccine efficacy against HZ was 92.4% (95% CI: 69.4-99.1%). As no PHN event was observed in the HZ/su group, the vaccine efficacy against PHN was 100% (95% CI: -58.7-100%). Vaccine efficacy against HZ and PHN remained high throughout 4 years of the study period. Robust humoral and CMI responses were observed and persisted throughout the study period in HZ/su recipients. Solicited reports of injection-site and systemic reactions within 7 days after injection were statistically significantly more frequent among HZ/su recipients than among placebo recipients. The frequency of serious adverse events, potential immune-mediated diseases, and deaths in the HZ/su recipients was similar to the placebo recipients and no statistically significant difference was found.

Based on above results, it can be concluded that HZ/su has demonstrated high efficacy as well as robust immunogenicity in the Japanese sub-population, in line with the results observed in the global studies. In terms of safety, no meaningful differences were detected between the Japanese population and the global population. HZ/su seems to be a valuable vaccine in Japanese elderly people.

[ Kansenshogaku Zasshi 92: 103-114, 2018 ]

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