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Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel

Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03331991
Acronym
HCP
Enrollment
2400
Registered
2017-11-06
Start date
2016-09-28
Completion date
2019-07-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Respiratory Tract Disease

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALinfluenza vaccine

exposure to influenza vaccine

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Clalit Research Institute
CollaboratorOTHER
Abt Associates
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Be aged ≥18 years old; * Work at the facility full-time (≥30 hours per week); * Have routine direct hands-on or face-to-face contact with patients (within 1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters; * Continuous membership in Clalit Health plan for at least 1 year prior to enrollment.

Exclusion criteria

* No routine direct patient contact; * Works part-time; * Already received current season's flu vaccine more than 48 hours before enrollment and, thus, cannot complete blood draw prior to full immune response to the vaccine; * Not be a member of the Clalit Health System health plan.

Design outcomes

Primary

MeasureTime frame
Frequency of acute respiratory illness among healthcare personnel receiving influenza vaccine3 years
Proportion of work days missed associated with self-reported acute respiratory illness3 years

Secondary

MeasureTime frame
Frequency of asymptomatic and symptomatic infections (with typical or atypical symptom manifestations) with influenza viruses (and other viruses)3 years
Knowledge, attitudes, and practices (KAP) that predict vaccination hesitancy and refusal among healthcare personnel3 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026