Influenza Clinical Trial
Official title:
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
The purpose of the study on the Prevention of Influenza and Other Wintertime Respiratory Viruses among Healthcare Professionals in Israel Effectiveness of Influenza Vaccine in Preventing Influenza Virus Infection, Missed Work, and Patient Exposure: A Prospective Cohort Study of Healthcare Personnel (to be called the Healthcare Personnel or HCP study throughout this Data Security Plan) is to investigate vaccine effectiveness and respiratory illness among healthcare personnel (HCP). This will help to better understand the factors that influence influenza vaccination choice, individual vaccine response, and whether or not the influenza vaccine helps to prevent influenza in HCP.
Healthcare personnel (HCP) are believed to be at increased risk of influenza infection and
often work while ill, which increases the risk of secondary exposure to vulnerable patients.
Vaccination of HCP against influenza is an important component of infection control in
healthcare settings, but persistently low rates of vaccine uptake among HCP remains a topic
of international concern and debate. Although recent reviews confirm that the seasonal
influenza vaccine is moderately effective in reducing the risk of influenza illness [10],
multiple gaps in knowledge remain regarding the preventive value of vaccine among HCP.
During at least two consecutive influenza seasons or years, this prospective cohort study of
healthcare personnel in middle-income countries has four primary objectives: (1) Describe the
frequency and impact of acute respiratory illnesses (ARI) among HCP during wintertime; (2)
Estimate the effectiveness of influenza vaccine in preventing symptomatic influenza illness,
missed work due to influenza illness, and hours of direct patient care provided by HCP with
symptomatic influenza infections; (3) Examine the association between repeated influenza
vaccination and HCP's baseline immune landscape, their response to influenza vaccines, and
their subsequent protection against infection; (4) Examine if influenza vaccine modifies
symptom severity and duration among HCP with breakthrough influenza infections despite
vaccination.
Approximately 2,400-2,800 HCP providing direct patient care will be enrolled in a prospective
cohort to be followed for at least two years (or two influenza seasons). In Israel,
approximately 1,200 HCPs will be enrolled in Year 1 of the study, with an expansion to full
enrollment in Year 2. Thus, the investigators anticipate a 3 year cohort study in which
~1,200 participants will contribute to years 1 and 2 of the study and the remaining sample
will contribute to years 2 and 3 of the study. Information on socio-demographic
characteristics, current medical conditions, medical history, medical care utilization, and
influenza vaccination history will be extracted from medical and employee records with the
participant's permission. Other information on socio-demographics, occupational
responsibilities, health status, and knowledge and attitudes about viruses and vaccines will
be collected by self-report through an enrollment survey. Collection of blood specimens will
occur prior to and after influenza seasons during each study year; in addition, HCP who
receive the influenza vaccine will provide an additional blood draw 21-42 days after
vaccination. Active surveillance to identify acute illnesses (associated with cough, runny
nose, body aches, or feverishness) will occur twice-weekly during weeks of local influenza
circulation. When an acute illness is identified, participants will provide a respiratory
specimen (nasal self-swab) for influenza testing and complete two brief surveys during and
after resolution of their illness. For a sub-sample of consented participants, additional
information on attitudes toward morbidity with influenza and respiratory illness will be
collected through in-depth qualitative interviews. Additional brief surveys will be completed
at the end of each season/year and at the start of the second influenza season to update
information on participant health, work responsibilities, and attitudes and practices
associated with vaccination and other inflection control and prevention measures.
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