title: Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age.
abstract: BACKGROUND
  An adjuvanted varicella-zoster virus glycoprotein E (gE) subunit vaccine candidate for herpes zoster is in development. In this trial we compared the safety, reactogenicity, and immunogenicity of the vaccine antigen combined with different adjuvant doses.
  
  
  METHODS
  This was a phase II, observer-blind, randomized, multinational study. Adults ≥50 years old were randomized 4:4:2:1 to be vaccinated at months 0 and 2 with gE combined with a higher (AS01B) or lower (AS01E) dose adjuvant, unadjuvanted gE, or saline. Following each dose, solicited events were recorded for 7 days and unsolicited adverse events for 30 days. Serious adverse events were collected for 1 year. Cell-mediated and humoral immune responses were assessed at baseline and following each dose.
  
  
  RESULTS
  No vaccine-related severe adverse events were reported. Solicited adverse events were generally mild to moderate and transient. For all gE-based vaccines, pain was the most common local symptom and fatigue the most common general symptom. Immune responses were significantly enhanced by AS01B and AS01E compared to unadjuvanted gE and were significantly stronger for gE/AS01B than for gE/AS01E.
  
  
  CONCLUSIONS
  AS01 improved the immunogenicity of gE while retaining acceptable safety and reactogenicity profiles. The enhancement of gE-specific cellular and humoral responses was adjuvant dose dependent.
  
  
  BACKGROUND
  NCT00802464.
authors.affiliation: Department of Epidemiology, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.
authors.forename: Roman
authors.initials: R
authors.lastname: Chlibek
authors.forename: José M
authors.initials: JM
authors.lastname: Bayas
authors.forename: Harry
authors.initials: H
authors.lastname: Collins
authors.forename: Maria Luisa Rodriguez
authors.initials: ML
authors.lastname: de la Pinta
authors.forename: Edouard
authors.initials: E
authors.lastname: Ledent
authors.forename: Johann F
authors.initials: JF
authors.lastname: Mols
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
mesh_terms: D000276:Adjuvants, Immunologic; D000368:Aged; D000914:Antibodies, Viral / Q000276:immunology; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D005260:Female; D006562:Herpes Zoster / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / 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
keywords: adjuvant; immunogenicity; recombinant subunit vaccine; safety; varicella-zoster virus