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A double-blind,double-dummy,randomized controlled trial to compare trivalent split virus influenza vaccine to seasonal prophylaxis with an antiviral drug in healthcare workers and other healthy adults in relation to the match between vaccine antigen

English title A double-blind,double-dummy,randomized controlled trial to compare trivalent split virus influenza vaccine to seasonal prophylaxis with an antiviral drug in healthcare workers and other healthy adults in relation to the match between vaccine antigen
Applicant Kuster Stefan P.
Number 125576
Funding scheme Fellowships for prospective researchers
Research institution Departement of Pathology and Lab. Medicine Mount Sinai Hospital
Institution of higher education Institution abroad - IACH
Main discipline Internal Medicine
Start/End 01.03.2010 - 28.02.2011
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All Disciplines (2)

Discipline
Internal Medicine
Medical Microbiology

Keywords (6)

influenza; epidemiology; vaccines; healthcare worker; relative risk; risk factors

Lay Summary (English)

Lead
Lay summary
Aim:
The aim of this study is to describe the relative risk and risk factors for influenza infection in healthcare workers by a new strain of influenza introduced into a susceptible cohort of healthy humans in 2009/10.

Background:
Influenza remains the most common infectious disease cause of death in the developed world. Nevertheless, only few data are available regarding risk factors for influenza infection in adults. Working in a healthcare setting is often mentioned to increase the risk for influenza infection. However, there are no studies that directly compare the risk of influenza infection in healthcare workers and other adults.

Methods:
The Influenza Cohort Study is a prospective study recruiting subjects to evaluate the current 2009/10 influenza pandemic. A cohort of adults >18 years of age who are employed full- or part-time in an acute care setting or in non-healthcare-related settings, and household members from subjects from each of these settings, are followed for the duration of the actual influenza pandemic. There are no exclusion criteria. An estimated 1200 study subjects will be included.
Healthcare workers are recruited from 8 acute-care hospitals in Ontario, Canada. Non-healthcare workers are recruited from several large Toronto employers.

Eligible primary household contacts are asked to complete a baseline household questionnaire detailing the number, ages, and work/school/day care attendance for each household member. The personal questionnaire details their influenza vaccination history, demographic data, potential work- or school-related risk factors for respiratory virus infection and potential community risk factors.
Blood samples are collected from consenting participants 16 years of age and older, at baseline and again at the end of the outbreak, to determine asymptomatic infection with influenza.
During the study, all participants 16 years of age and older are asked to complete weekly diaries detailing any respiratory symptoms and acute respiratory or febrile illnesses, documenting time-dependent risk factors such as contact with people who have symptoms of an acute respiratory illness, and work/school/day care attendance for the week.
All subjects are asked to provide a nasopharyngeal or nasal swab if they develop any symptoms suggestive of an acute respiratory illness. In addition, they are asked to complete complete daily diaries for the duration of their illness.
Nasal swabs are tested by polymerase chain reaction for influenza at the study laboratory.
Direct link to Lay Summary Last update: 21.02.2013

Responsible applicant and co-applicants

Publications

Publication
Risk factors for influenza among health care workers during 2009 pandemic, Toronto, Ontario, Canada.
Kuster Stefan P, Coleman Brenda L, Raboud Janet, McNeil Shelly, De Serres Gaston, Gubbay Jonathan, Hatchette Todd, Katz Kevin C, Loeb Mark, Low Donald, Mazzulli Tony, Simor Andrew, McGeer Allison J, McGeer Allison J (2013), Risk factors for influenza among health care workers during 2009 pandemic, Toronto, Ontario, Canada., in Emerging infectious diseases, 19(4), 606-15.
Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study.
Coleman B L, Kuster S P, Gubbay J, Scheifele D, Li Y, Low D, Crowcroft N, Mazzulli T, Shi L, Halperin S A, Law B, McGeer A, McGeer A (2012), Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study., in European journal of clinical microbiology & infectious diseases : official publication of the Europe, 31(4), 591-7.
Evaluation of coseasonality of influenza and invasive pneumococcal disease: results from prospective surveillance.
Kuster Stefan P, Tuite Ashleigh R, Kwong Jeffrey C, McGeer Allison, McGeer Allison, Fisman David N (2011), Evaluation of coseasonality of influenza and invasive pneumococcal disease: results from prospective surveillance., in PLoS medicine, 8(6), 1001042-1001042.
Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis.
Kuster Stefan P, Shah Prakesh S, Coleman Brenda L, Lam Po-Po, Tong Agnes, Wormsbecker Anne, McGeer Allison (2011), Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis., in PloS one, 6(10), 26239-26239.
When should a diagnosis of influenza be considered in adults requiring intensive care unit admission? Results of population-based active surveillance in Toronto.
Kuster Stefan P, Katz Kevin C, Blair Joanne, Downey James, Drews Steven J, Finkelstein Sandy, Fowler Rob, Green Karen, Gubbay Jonathan, Hassan Kazi, Lapinsky Stephen E, Mazzulli Tony, McRitchie Donna, Pataki Janos, Plevneshi Agron, Powis Jeff, Rose David, Sarabia Alicia, Simone Carmine, Simor Andrew, McGeer Allison (2011), When should a diagnosis of influenza be considered in adults requiring intensive care unit admission? Results of population-based active surveillance in Toronto., in Critical care (London, England), 15(4), 182-182.
Epidemiology of influenza-associated hospitalization in adults, Toronto, 2007/8.
Kuster S P, Drews S, Green K, Blair J, Davis I, Downey J, Fowler R, Katz K, Lapinsky S, McRitchie D, Pataki J, Powis J, Rose D, Sarabia A, Simone C, Simor A, Stewart T, McGeer A (2010), Epidemiology of influenza-associated hospitalization in adults, Toronto, 2007/8., in European journal of clinical microbiology & infectious diseases : official publication of the Europe, 29(7), 835-43.

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
48th Annual Meeting of the Infectious Diseases Society of America (IDSA), 2010, Vancouver, Canada Talk given at a conference Efficacy and Safety of Adjuvanted 2009 pH1N1Influenza Virus Vaccine in Healthy Adults 21.10.2010 Vancouver, Canada Kuster Stefan P.;
50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), 2010, Boston, USA Talk given at a conference Differences in Epidemiological Characteristics between Seasonal and Pandemic (H1N1) 2009 Influenza requiring Intensive Care Unit admission, Toronto, 2007/08-2009/10 12.09.2010 Boston, United States of America Kuster Stefan P.;


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