A system to rapidly assess influenza vaccine effectiveness (VE) is needed.
The aims of this research are to 1) generate annual estimates of direct VE for prevention of laboratory-confirmed influenza in a noninstitutionalized population-based cohort; 2) provide rapid assessment of VE at regular intervals during the influenza season; and 3) provide estimates of vaccine effectiveness in higher risk age groups. The Marshfield Clinic (MC) infrastructure offers three key strengths to conduct this research: l) a well-defined, stable population cohort of about 50,000 people living in 14 zip codes (Marshfield Epidemiologic Study Area, or MESA); 2) a comprehensive, real-time, internet-based immunization registry that includes all public and private immunization providers serving this population; and 3) a functioning syndromic surveillance system to rapidly identify incident cases of medically-attended acute respiratory illness (MAARI). METHODS: This will be a prospective cohort study using a fixed cohort based on the MESA population. The cohort will be divided into the following age strata: 6--23 months, 24 months through 8 years, 9--17 years, 18 49 years, 50--64 years, and 65+ years. The cohort will be defined on November 1, 2004, and influenza immunization status will be monitored in real-time. Each age strata will be further stratified into high-risk and normal-risk based on the presence or absence of certain chronic diseases. We will identify and enroll cohort members who have MA.ARI during the influenza epidemic period. We will attempt to enroll all MAARI cases in the priority age groups for whom influenza vaccine is recommended: children 6 months through 23 months old, and adults > 50 years old. We will employ a sampling strategy for MAARI occurring in other age groups (2 years--49 years). A nasal or nasopharyngeal swab will be collected from enrolled patients for viral culture. Patients with MAARI will be identified and enrolled using two procedures: 1) same-day recruitment during a clinic visit to Pediatrics or Urgent Care, and 2) next-day enrollment using syndromic surveillance, which will identify patients with MAAR/visits on the previous day at all MC locations. ANALYSIS: Efficacy of the influenza vaccine will be estimated as VE=I-RR where RR denotes the relative risk of laboratory-confirmed influenza in the vaccinated group compared to the unvaccinated group. Initially, all members of the influenza study cohort will be classified in strata defined by MAARI status, vaccination status, age group and high- risk status. In each MAAR/stratum, enrolled subjects will be assigned an analytic weight equal to the number of people in the study cohort for the stratum divided by the number of enrolled subjects in the stratum. Overall VE estimates will be adjusted for age group, high-risk status and resource utilization. We will compute cumulative VE estimates at weeks 4, 8 and 12 of the influenza season. In addition, separate 4-week estimates for weeks 5-8 and 9-12 will be computed. We will use a variety of analytic procedures to identify potential sources of bias and confounding. Interim and annual estimates of VE with 95% confidence intervals will be provided to CDC, including overall VE and VE for each of the priority age groups.
|VanWormer, Jeffrey J; Sundaram, Maria E; Meece, Jennifer K et al. (2014) A cross-sectional analysis of symptom severity in adults with influenza and other acute respiratory illness in the outpatient setting. BMC Infect Dis 14:231|
|Bateman, Allen C; Kieke, Burney A; Irving, Stephanie A et al. (2013) Effectiveness of monovalent 2009 pandemic influenza A virus subtype H1N1 and 2010-2011 trivalent inactivated influenza vaccines in Wisconsin during the 2010-2011 influenza season. J Infect Dis 207:1262-9|
|Irving, Stephanie A; Vandermause, Mary F; Shay, David K et al. (2012) Comparison of nasal and nasopharyngeal swabs for influenza detection in adults. Clin Med Res 10:215-8|
|Irving, Stephanie A; Patel, Darshan C; Kieke, Burney A et al. (2012) Comparison of clinical features and outcomes of medically attended influenza A and influenza B in a defined population over four seasons: 2004-2005 through 2007-2008. Influenza Other Respir Viruses 6:37-43|
|Belongia, Edward A; Kieke, Burney A; Donahue, James G et al. (2011) Influenza vaccine effectiveness in Wisconsin during the 2007-08 season: comparison of interim and final results. Vaccine 29:6558-63|
|Coleman, Laura A; Kieke, Burney; Irving, Stephanie et al. (2011) Comparison of influenza vaccine effectiveness using different methods of case detection: clinician-ordered rapid antigen tests vs. active surveillance and testing with real-time reverse-transcriptase polymerase chain reaction (rRT-PCR). Vaccine 29:387-90|
|Belongia, Edward A; Irving, Stephanie A; Waring, Stephen C et al. (2010) Clinical characteristics and 30-day outcomes for influenza A 2009 (H1N1), 2008-2009 (H1N1), and 2007-2008 (H3N2) infections. JAMA 304:1091-8|
|Irving, Stephanie A; Donahue, James G; Shay, David K et al. (2009) Evaluation of self-reported and registry-based influenza vaccination status in a Wisconsin cohort. Vaccine 27:6546-9|
|Belongia, Edward A; Kieke, Burney A; Donahue, James G et al. (2009) Effectiveness of inactivated influenza vaccines varied substantially with antigenic match from the 2004-2005 season to the 2006-2007 season. J Infect Dis 199:159-67|
|Rahman, Mahbubur; Bright, Rick A; Kieke, Burney A et al. (2008) Adamantane-resistant influenza infection during the 2004-05 season. Emerg Infect Dis 14:173-6|
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