title: Safety, tolerability, and immunogenicity of zoster vaccine in subjects on chronic/maintenance corticosteroids.
abstract: BACKGROUND
  This randomized, placebo-controlled study assessed the safety, tolerability, and immunogenicity of live virus zoster vaccine (ZV) in individuals receiving chronic/maintenance systemic corticosteroid therapy (daily dose equivalent of 5-20mg prednisone) for ≥2 weeks prior to vaccination and ≥6 weeks postvaccination.
  
  
  METHODS
  Subjects were followed for adverse experiences (AEs), exposure to varicella or herpes zoster (HZ), or development of varicella/varicella-like or HZ/HZ-like rashes for 42 days postvaccination (primary safety follow-up period) and for serious AEs (SAEs) through Day 182 postvaccination (secondary follow-up period). Varicella-zoster virus (VZV) antibody titers by glycoprotein enzyme-linked immunosorbent assay (gpELISA) were measured at baseline and at Week 6 postvaccination.
  
  
  RESULTS
  The proportions of subjects reporting systemic AEs and SAEs were similar in both groups. A higher percentage of subjects reported injection-site AEs in the ZV group (21.5%) than in the placebo group (12.1%). One SAE of ophthalmic HZ (onset Day 16 postvaccination) was reported in the ZV group and deemed vaccine-related by the study investigator; however, PCR testing confirmed the presence of wild-type (not vaccine strain) VZV. Geometric mean titer (GMT) at 6 weeks postvaccination was higher for ZV recipients than placebo recipients, with estimated geometric mean fold rises (GMFR) of 2.3 (CI: 2.0, 2.7) and 1.1 (CI: 1.0, 1.2) respectfully.
  
  
  CONCLUSIONS
  In adults ≥60 years old on chronic/maintenance corticosteroids, ZV was generally well tolerated and immunogenic. The VZV-specific gpELISA antibody GMT at 6 weeks postvaccination and the GMFR from baseline to 6 weeks postvaccination were higher in the ZV group than in the placebo group.
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA. Electronic address: amy_russell@merck.com.
authors.forename: Amy F
authors.initials: AF
authors.lastname: Russell
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Janie
authors.initials: J
authors.lastname: Parrino
authors.affiliation: Health Research of Hampton Roads, Newport News, VA, USA.
authors.forename: Chester L
authors.initials: CL
authors.lastname: Fisher
authors.affiliation: Rheumatology Specialty Practice, Zerbst, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Spieler
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Kathleen E
authors.initials: KE
authors.lastname: Coll
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Shu-Chih
authors.initials: SC
authors.lastname: Su
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Jin
authors.initials: J
authors.lastname: Xu
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Li
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Katia
authors.initials: K
authors.lastname: Schlienger
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Silber
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D002644:Chickenpox / Q000453:epidemiology / Q000517:prevention & control; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006562:Herpes Zoster / Q000453:epidemiology / Q000517:prevention & control; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000305:Adrenal Cortex Hormones; D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D007166:Immunosuppressive Agents; D010919:Placebos; D014613:Vaccines, Attenuated
keywords: Herpes zoster; Immunogenicity; Safety; Tolerability; Zoster vaccine