title: Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly.
abstract: The impact of alternate routes of vaccine administration, subcutaneous (SC) or intramuscular (IM), on the safety and immunogenicity of herpes zoster subunit candidate vaccine (HZ/su) was assessed in Japanese adults aged ≥ 50 y. During this phase III open-label study, 60 subjects were randomized (1:1) to receive HZ/su through SC or IM routes in a 0, 2 month schedule. Vaccine response rates (VRRs) and geometric mean concentrations (GMCs) of varicella zoster virus glycoprotein E (gE)-specific antibodies were determined by ELISA. Solicited and unsolicited symptoms were recorded for 7 and 30 d after each vaccination and graded 1-3 in severity. Serious adverse events (SAEs) were recorded throughout the study. At one month post-dose 2, VRRs were 100% (95% Confidence Interval (CI): 88.1-100) in both groups; anti-gE antibody GMCs were 44126.1 mIU/ml (95% CI: 36326.1-53601.0) and 45521.5 mIU/ml (95% CI; 37549.5-55185.9) in the SC and IM groups, respectively. Injection site reactions (pain, swelling and redness) were common, and observed more frequently following SC administration. Grade 3 redness and swelling were more frequently observed after SC administration. Fatigue and headache were the most frequently reported general symptoms for both routes of administration. Ten and 7 unsolicited AEs were reported in the SC and IM group, respectively. Two unsolicited AEs (1 in SC; 1 in IM) were considered related to vaccination by the investigator. Three non-fatal SAEs considered unrelated to vaccination were reported during the study. Administration of the HZ/su vaccine candidate resulted in a substantial immune response that was comparable between SC and IM subjects, but local reactogenicity may be greater for SC.
authors.affiliation: a GSK Vaccines , Rockville , MD , USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Vink
authors.affiliation: b SOUSEKAI PS Clinic , Tenyamachi, Hakata-ku, Fukuoka , Japan.
authors.forename: Masanari
authors.initials: M
authors.lastname: Shiramoto
authors.affiliation: c Japan Vaccine Company Ltd. , Chiyoda-ku , Tokyo , Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ogawa
authors.affiliation: c Japan Vaccine Company Ltd. , Chiyoda-ku , Tokyo , Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Eda
authors.affiliation: d GSK Vaccines , Wavre , Belgium.
authors.forename: Martine
authors.initials: M
authors.lastname: Douha
authors.affiliation: a GSK Vaccines , Rockville , MD , USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Heineman
authors.affiliation: a GSK Vaccines , Rockville , MD , USA.
authors.forename: Himal
authors.initials: H
authors.lastname: Lal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D007564:Japan; D008297:Male; D008875:Middle Aged; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014759:Viral Envelope Proteins / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D022223:Vaccines, Subunit; D014759:Viral Envelope Proteins; C056913:glycoprotein E, varicella-zoster virus
keywords: HZ/su vaccine; adjuvant; adjuvanted vaccine; herpes zoster; immunogenicity; intramuscular; reactogenicity; subcutaneous