passages: 2298
passages: document
passages: Safety , tolerability , and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age . BACKGROUND Incidence and severity of herpes zoster ( HZ ) and postherpetic neuralgia increase with age , associated with age-related decrease in immunity to varicella-zoster virus ( VZV ) . One dose of zoster vaccine ( ZV ) has demonstrated substantial protection against HZ ; this study examined impact of a second dose of ZV . METHODS Randomized , double-blind , multicenter study with 210 subjects ≥60 years old compared immunity and safety profiles after one and two doses of ZV , separated by 6 weeks , vs. placebo . Immunogenicity was evaluated using VZV interferon-gamma ( IFN-γ ) enzyme-linked immunospot ( ELISPOT ) assay and VZV glycoprotein enzyme-linked immunosorbent antibody ( gpELISA ) assay . Adverse experiences ( AEs ) were recorded on a standardized Vaccination Report Card . RESULTS No serious vaccine-related AEs occurred . VZV IFN-γ ELISPOT geometric mean count ( GMC ) of spot-forming cells per 10 ( 6 ) peripheral blood mononuclear cells increased in the ZV group from 16.9 prevaccination to 49.5 and 32.8 at 2 and 6 weeks postdose 1 , respectively . Two weeks , 6 weeks and 6 months postdose 2 , GMC was 44.3 , 42.9 , and 36.5 , respectively . GMC in the placebo group did not change during the study . The peak ELISPOT response occurred ∼2 weeks after each ZV dose . The gpELISA geometric mean titers ( GMTs ) in the ZV group were higher than in the placebo group at 6 weeks after each dose . Correlation between the IFN-γ ELISPOT and gpELISA assays was poor . CONCLUSIONS ZV was generally well-tolerated and immunogenic in adults ≥60 years old . A second dose of ZV was generally safe , but did not boost VZV-specific immunity beyond levels achieved postdose 1 .
entities: 2299
entities: Intervention_Pharmacological
entities: zoster vaccine
entities: 2300
entities: Intervention_Pharmacological
entities: zoster vaccine ( ZV )
entities: 2301
entities: Intervention_Control
entities: placebo
entities: 2302
entities: Intervention_Control
entities: placebo
entities: 2303
entities: Outcome_Other
entities: Safety
entities: 2304
entities: Outcome_Other
entities: tolerability
entities: 2305
entities: Outcome_Physical
entities: immunogenicity
entities: 2306
entities: Outcome_Physical
entities: immunity
entities: 2307
entities: Outcome_Other
entities: safety
entities: 2308
entities: Outcome_Physical
entities: Immunogenicity
entities: 2309
entities: Outcome_Adverse-effects
entities: Adverse experiences ( AEs )
entities: 2310
entities: Outcome_Adverse-effects
entities: serious vaccine-related
entities: 2311
entities: Participant_Condition
entities: healthy
entities: 2312
entities: Participant_Age
entities: adults ≥60 years of age
entities: 2313
entities: Participant_Sample-size
entities: 210
entities: 2314
entities: Participant_Age
entities: ≥60 years