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.

Study of the impact of oseltamivir on the risk for pneumonia and other outcomes of influenza, 2000-2005.

CONTEXT: Influenza results in large numbers of secondary complications and hospitalizations. OBJECTIVE: To assess the impact of oseltamivir on influenza-related complications and hospitalizations by analyzing health insurance claims data for 6 influenza seasons. DESIGN: A retrospective cohort study utilizing claims data from the 2000-2005 influenza seasons. SETTING: Claims data were obtained from Thomson Healthcare MarketScan Research Databases. PATIENTS: Patients prescribed oseltamivir within 1 day of influenza diagnosis were compared to those prescribed no antiviral therapy (controls). OUTCOMES: Frequencies of pneumonia, other respiratory illnesses, and otitis media, and rates of hospitalization, were compared for the oseltamivir and no antiviral groups. Expenditure was also analyzed. Relative risk (RR) for each outcome was assessed using Cox proportional hazards regression. RESULTS: Overall, 31,674 patients received oseltamivir and were propensity matched to patients with no antiviral prescription. Oseltamivir reduced the risk of diagnosis of pneumonia by 15% (RR 0.85, 95% confidence interval [CI] 0.73, 0.98), other respiratory illnesses by 20% (RR 0.80, 95% CI: 0.76, 0.83), and otitis media and its complications by 31% (RR 0.69, 95% CI: 0.61, 0.79). The greatest reductions in pneumonia risk, of 57% and 52%, were observed for children aged 6-12 years (RR 0.43, 95% CI: 0.26, 0.71) and 1-2 years (RR 0.48, 95% CI: 0.24, 0.99), respectively. Overall, hospitalization rates were reduced by 38% (RR 0.62, 95% CI: 0.52, 0.74) in the oseltamivir group compared with the no antiviral group. Total adjusted expenditures in the oseltamivir and no antiviral groups were not significantly different. CONCLUSIONS: Oseltamivir reduced the relative risk of influenza-related complications and hospitalization when prescribed immediately upon presentation of influenza.