title: Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial.
abstract: This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 and ≥ 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3). Solicited local and general adverse events (AEs) were recorded for 7 d and unsolicited AEs for 30 d after each vaccination. Serious AEs were recorded until study end. The primary immunogenicity objective was met if the lower limit of the 95% confidence interval (CI) of the vaccine response rate (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was ≥ 60%. 96 participants (32/age group) were enrolled. The primary immunogenicity objective was met, as the VRR at Month 3 was 90.2% (95% CI: 81.7-95.7). Geometric mean anti-gE antibody concentrations at Month 3 were similar across age groups. 77.9% and 71.6% of participants reported local and general solicited AEs, respectively. The most frequent solicited AEs were pain at injection site, fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in adults aged ≥ 50 y with a physician-documented history of HZ, and no safety concerns were identified.
authors.affiliation: a GSK Vaccines , Wavre , Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Godeaux
authors.affiliation: a GSK Vaccines , Wavre , Belgium.
authors.forename: Martina
authors.initials: M
authors.lastname: Kovac
authors.affiliation: b Gain Medical Centre , Coquitlam , BC , Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Shu
authors.affiliation: a GSK Vaccines , Wavre , Belgium.
authors.forename: Katrijn
authors.initials: K
authors.lastname: Grupping
authors.affiliation: a GSK Vaccines , Wavre , Belgium.
authors.forename: Laura
authors.initials: L
authors.lastname: Campora
authors.affiliation: a GSK Vaccines , Wavre , Belgium.
authors.forename: Martine
authors.initials: M
authors.lastname: Douha
authors.affiliation: c GSK Vaccines , King of Prussia , PA , USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
authors.affiliation: c GSK Vaccines , King of Prussia , PA , USA.
authors.forename: Himal
authors.initials: H
authors.lastname: Lal
mesh_terms: D000276:Adjuvants, Immunologic; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D000917:Antibody Formation; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D064420:Drug-Related Side Effects and Adverse Reactions; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006562:Herpes Zoster / Q000276:immunology / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D000071497:Immunogenicity, Vaccine; D008297:Male; D008875:Middle Aged; D022223:Vaccines, Subunit / Q000276:immunology; D014759:Viral Envelope Proteins / Q000276:immunology
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: herpes zoster; immunogenicity; safety; varicella-zoster virus; zoster vaccine