title: Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study.
abstract: BACKGROUND
  This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E (gE) with or without the adjuvant system AS01B.
  
  
  METHODS
  In this phase II, single-blind, randomized, controlled study, adults aged ≥60years (N=714) received one dose of 100μggE/AS01B, two doses, two months apart, of 25, 50, or 100μggE/AS01B, or two doses of unadjuvanted 100μggE/saline. Frequencies of CD4(+) T cells expressing ≥2 activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA.
  
  
  RESULTS
  Frequencies of gE-specific CD4(+) T cells were >3-fold higher after two doses of all gE/AS01B formulations than after one dose of 100μggE/AS01B or two doses of 100μggE/saline. Frequencies were comparable after two doses of 25, 50, or 100μggE/AS01B. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100μggE/AS01B and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01B formulations were similar but greater than with gE/saline.
  
  
  CONCLUSIONS
  The three formulations of gE/AS01B were immunogenic and well tolerated in adults aged ≥60years. Two vaccinations with gE/AS01B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).
authors: Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.
authors: Roman
authors: R
authors: Chlibek
authors: Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic. Electronic address: smetana@pmfhk.cz.
authors: Jan
authors: J
authors: Smetana
authors: Department of Medical Science, Section of Infectious Diseases, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden.
authors: Karlis
authors: K
authors: Pauksens
authors: Clinical Research Center, Sormland County Council, Eskilstuna, Sweden; Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.
authors: Lars
authors: L
authors: Rombo
authors: Public Health Service Amsterdam, The Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Centre, Amsterdam, The Netherlands.
authors: J Anneke R
authors: JA
authors: Van den Hoek
authors: Municipal Public Health Service Rotterdam-Rijnmond, Rotterdam, The Netherlands.
authors: Jan H
authors: JH
authors: Richardus
authors: Unterfrintroper Hausarztzentrum, Essen, Germany.
authors: Georg
authors: G
authors: Plassmann
authors: Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany.
authors: Tino F
authors: TF
authors: Schwarz
authors: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors: Edouard
authors: E
authors: Ledent
authors: GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
authors: Thomas C
authors: TC
authors: Heineman
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D053061:Herpes Zoster Vaccine / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use; D006801:Humans; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D007115:Immunization Schedule; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D022223:Vaccines, Subunit
keywords: Adjuvant; Herpes zoster; Vaccine; Varicella-zoster virus; gE