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

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ClinicalTrials.gov Identifier: NCT03331991
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Clalit Research Institute
Information provided by (Responsible Party):
Abt Associates

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.

Condition or disease Intervention/treatment
Respiratory Tract Disease Influenza Biological: influenza vaccine

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.


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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot


Intervention Details:
  • Biological: influenza vaccine
    exposure to influenza vaccine


Primary Outcome Measures :
  1. Frequency of acute respiratory illness among healthcare personnel receiving influenza vaccine [ Time Frame: 3 years ]
  2. Proportion of work days missed associated with self-reported acute respiratory illness [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Frequency of asymptomatic and symptomatic infections (with typical or atypical symptom manifestations) with influenza viruses (and other viruses) [ Time Frame: 3 years ]
  2. Knowledge, attitudes, and practices (KAP) that predict vaccination hesitancy and refusal among healthcare personnel [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood specimens and respiratory specimens will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthcare personnel
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331991


Contacts
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Contact: Gabriella Newes-Adeyi, PhD, MPH (301) 634-1758 Gabriella_Newes-Adeyi@abtassoc.com
Contact: Rachael Wendlandt, MPH 404-946-6377 Rachael_Wendlandt@abtassoc.com

Locations
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Israel
Soroka Medical Center Recruiting
Beer sheva, Israel, 85025
Contact: Avital Hirsch, MPH         
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Avital Hirsch, MPH         
Sponsors and Collaborators
Abt Associates
Centers for Disease Control and Prevention
Clalit Research Institute
Investigators
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Principal Investigator: Mark Thompson, PhD Centers for Disease Control and Prevention

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abt Associates
ClinicalTrials.gov Identifier: NCT03331991     History of Changes
Other Study ID Numbers: HHSD2002013M53890B
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs