title: Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and low-seropositive healthy adults.
abstract: OBJECTIVE
  To evaluate immunogenicity and tolerability of a live attenuated zoster vaccine in varicella-zoster virus (VZV) seronegative or low-seropositive adults > or = 30 years of age.
  
  
  METHODS
  Double-blind, placebo-controlled, randomized, multicenter study. Subjects were enrolled in two stages by prescreened serostatus. Subjects with a low VZV antibody titer (< or = 5 gpELISA units/mL) were enrolled in Stage 1. Subjects with undetecable VZV antibodies and no safety issues identified during Stage 1 were enrolled in Stage 2. All enrolled subjects were randomized 4:1 to receive one dose (approximately 50,000 PFU) of zoster vaccine or placebo and were followed for safety for 42 days postvaccination. Primary objectives/hypotheses: (1) no vaccine-related serious adverse experiences (AE); (2) < or = 1 laboratory-confirmed varicella-like rash with > 50 lesions within 42 days postvaccination.
  
  
  OBJECTIVE
  summarize the VZV antibody response postvaccination.
  
  
  RESULTS
  Twenty-one subjects (age 27 to 69 years; median 34) enrolled (1148 prescreened); 18 (including 4 seronegative subjects) received vaccine and 3 (including 1 seronegative subject) received placebo. Twenty subjects completed the study; one subject withdrew for reasons unrelated to safety. No serious vaccine-related AE or laboratory-confirmed varicella-like rashes with > 50 lesions were reported. In the zoster vaccine group, all 4 of the initially seronegative subjects (age 32 to 36 years; median 33.5) seroconverted and 6 of the 13 (46.2%) initially seropositive subjects had a > or = 4-fold rise in VZV-specific antibody titer at 6 weeks postvaccination.
  
  
  CONCLUSIONS
  The zoster vaccine appears to be immunogenic and generally well tolerated in healthy adults > or = 30 years of age, regardless of initial VZV antibody serostatus.
authors.affiliation: De la Salle University Medical Center, Cavite, Philippines.
authors.forename: N
authors.initials: N
authors.lastname: Macaladad
authors.forename: T
authors.initials: T
authors.lastname: Marcano
authors.forename: M
authors.initials: M
authors.lastname: Guzman
authors.forename: J
authors.initials: J
authors.lastname: Moya
authors.forename: F
authors.initials: F
authors.lastname: Jurado
authors.forename: M
authors.initials: M
authors.lastname: Thompson
authors.forename: C
authors.initials: C
authors.lastname: Meechan
authors.forename: D
authors.initials: D
authors.lastname: Li
authors.forename: K
authors.initials: K
authors.lastname: Schlienger
authors.forename: I
authors.initials: I
authors.lastname: Chan
authors.forename: J
authors.initials: J
authors.lastname: Sadoff
authors.forename: F
authors.initials: F
authors.lastname: Schödel
authors.forename: J L
authors.initials: JL
authors.lastname: Silber
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D004311:Double-Blind Method; D005076:Exanthema; D005260:Female; D006562:Herpes Zoster / Q000276:immunology* / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000009:adverse effects* / Q000276:immunology*; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D010919:Placebos; D014613:Vaccines, Attenuated