title: Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults.
abstract: An adjuvanted recombinant subunit candidate vaccine (HZ/su) containing varicella zoster virus envelope glycoprotein E was developed for the prevention of herpes zoster and its complications. This study evaluated safety and reactogenicity of HZ/su in an ethnic Japanese population. This was a phase I, open-label and single-center study conducted between March and November of 2010 in Australia. Twenty healthy ethnic Japanese subjects, aged 18-30 y and 50-69 y (1:1) were enrolled. Subjects were administered two doses of HZ/su vaccine according to a 0, 2-mo schedule. Local and general solicited symptoms were recorded for 7 d post-vaccination. Unsolicited symptoms were recorded for 30 d post-vaccination. Serious adverse events (SAEs), new onset of autoimmune disease (NOAD), other potential immune mediated disorders and HZ cases were recorded throughout the study period. All 20 subjects were included in the according-to-protocol cohort for safety. A total of 18 subjects were included in the according-to-protocol cohort for immunogenicity: 10 in the 18-30 y age group and 8 in the 50-69 y age group. The most commonly reported local and general solicited symptoms were pain and fatigue in both groups. Back pain (in the 18-30 y age group) and chills (in the 50-69 y age group) were the most frequently reported unsolicited symptoms. There were no reports of death, SAEs, NOADs, other autoimmune mediated inflammatory disorder or suspected HZ cases. This study indicated that the two-dose regimen of HZ/su exhibited a clinically acceptable safety profile in healthy young and older ethnic Japanese adults.
authors.affiliation: GlaxoSmithKline Vaccines; King of Prussia, PA USA.
authors.forename: Himal
authors.initials: H
authors.lastname: Lal
authors.forename: Toufik
authors.initials: T
authors.lastname: Zahaf
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000276:immunology; D000917:Antibody Formation / Q000276:immunology; D005260:Female; D006562:Herpes Zoster / Q000276:immunology / Q000517:prevention & control; D053061:Herpes Zoster Vaccine / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use*; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000009:adverse effects; D022223:Vaccines, Subunit / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use*; D014759:Viral Envelope Proteins / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D022223:Vaccines, Subunit; D014759:Viral Envelope Proteins; C056913:glycoprotein E, varicella-zoster virus
keywords: Japanese; adjuvant; herpes zoster vaccine; reactogenicity; safety; varicella-zoster virus