title: A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults.
abstract: BACKGROUND
  An adjuvanted recombinant varicella zoster virus (VZV) subunit vaccine is being developed for the prevention of herpes zoster and its complications.
  
  
  METHODS
  In a phase I/II, open-label, randomized, parallel-group study, older adults (50-70 years) received 2 doses 2 months apart of an adjuvanted recombinant glycoprotein E vaccine (HZ/su; n = 45), a live attenuated Oka strain VZV vaccine (OKA; n = 45), or HZ/su and OKA administered concomitantly (n = 45). To evaluate safety prior to administration in older adults, young adults (18-30 years) were vaccinated with 2 doses 2 months apart of HZ/su (n = 10) or OKA (n = 10). Safety and immunogenicity were assessed up to 42 months for older adults immunized with HZ/su and up to 12 months for all others.
  
  
  RESULTS
  Few grade 3 events and no severe adverse events were reported. Fatigue, myalgia, headache, and injection site pain were the most common solicited reactions for HZ/su and occurred more frequently than with OKA. CD4(+) T-cell and humoral immune responses were much higher with HZ/su than with OKA and remained elevated until 42 months. Addition of OKA to HZ/su did not increase immunogenicity.
  
  
  CONCLUSIONS
  In this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. Clinical Trial registration. NCT00492648 and NCT00492648.
authors.affiliation: Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium. Geert.LerouxRoels@UGent.be
authors.forename: Isabel
authors.initials: I
authors.lastname: Leroux-Roels
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.forename: Frédéric
authors.initials: F
authors.lastname: Clement
authors.forename: Pierre
authors.initials: P
authors.lastname: Vandepapelière
authors.forename: Ventzislav
authors.initials: V
authors.lastname: Vassilev
authors.forename: Edouard
authors.initials: E
authors.lastname: Ledent
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006023:Glycoproteins / Q000276:immunology; D006562:Herpes Zoster / Q000517:prevention & control; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000379:methods; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015678:Viral Structural Proteins / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D006023:Glycoproteins; D022223:Vaccines, Subunit; D015678:Viral Structural Proteins