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CompletedNCT04709003CoVEHPIUpdated Jul 20, 2022

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)

An observational study in Covid19, Corona Virus Infection and Vaccine Effectiveness, sponsored by Clalit Health Services. Completed at 6 sites in Israel. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Clalit Health Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,567
Ages
18 Years to 120 Years
Sex
All
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Study summary

Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine in preventing symptomatic infection, many questions about vaccine effectiveness, such as the effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for transmission, and duration of protection, can only be evaluated in real-world trials. The objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of Health guidelines, will be recruited, regardless of their intention to get the COVID-19 vaccine. A baseline serology sample and respiratory sample will be collected. Participants will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6 months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR; serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For each participant, data will be extracted from the Electronic Medical Record for the period of the study and retrospectively from 2010.

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Conditions studied

  • Covid19
  • Corona Virus Infection
  • Vaccine Effectiveness
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In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 1,567 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir, Beilinson, HaEmek, and Schneider)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any HCP at any of the participating hospitals who is
  • a member of Clalit Health Services
  • is eligible to get the Covid-19 vaccine
  • did not receive the first dose of COVID-19 vaccine more than 21 days prior to the enrollment date

Exclusion criteria

Exclusion Criteria:

-

Employees at any of the participating hospitals will be excluded if they are:

  • not a member of Clalit Health Services; or
  • not eligible to get the Covid-19 vaccine according to the Ministry of Health guidelines; or
  • Less than 18 years of age
  • Received first dose of COVID-19 vaccine more than 21 days prior to date of enrollment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,567 participants (actual)
Patient registry
No

Groups and cohorts

  • vaccinated

    participants who received the Covid-19 vaccine

    Diagnostic Test: Serologic test · Diagnostic Test: Respiratory swabs

  • unvaccinated

    participants who didn't received the Covid-19 vaccine

    Diagnostic Test: Serologic test · Diagnostic Test: Respiratory swabs

Interventions

  • Diagnostic testSerologic test

    A blood test to check antibodies type and amount

  • Diagnostic testRespiratory swabs

    PCR test to Covid-19

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What researchers measure

Primary outcomes

  1. COVID-19 vaccine effectiveness (VE)

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

    Time frame: 18 months

Secondary outcomes

  1. Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers

    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

    Time frame: 18 months

  2. asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers

    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

    Time frame: 18 months

  3. Duration of effectiveness of the vaccine

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers over different periods of time

    Time frame: 18 months

  4. Vaccine Effectiveness by age

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers of different age groups

    Time frame: 18 months

  5. Vaccine Effectiveness by comorbidity

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers by various underly medical conditions

    Time frame: 18 months

  6. Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus

    Incidence of SARS-CoV-2 infections in previously infection healthcare workers vaccinated with COVID-19 vaccine compared to previously infection unvaccinated healthcare workers

    Time frame: 18 months

  7. VE by degree of exposure to COVID-19 patients

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers by degree of occupational exposure to COVID-019 patients

    Time frame: 18 months

  8. VE by different SARS-CoV-2 variants

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers for different variant strains of SARS-CoV-2

    Time frame: 18 months

  9. Vaccine effectiveness of one dose compared to two doses

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with two doses of COVID-19 vaccine compared to healthcare workers vaccinated with two doses of COVID-19 vaccine

    Time frame: 18 months

  10. Compartive vaccine Effectiveness of different vaccine brands

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine

    Time frame: 18 months

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Study locations

6 sites
  • Haemek Medical Center
    Afula, Israel
  • Soroka Medical Center
    Be'er Sheva, Israel
  • Meir Medical Center
    Kefar Saba, Israel
  • Beilinson hospital
    Petach Tikva, Israel
  • Schneider Children's Medical Center of Israel
    Petah tikva, Israel
  • Kaplan Medical Center
    Reẖovot, Israel
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04709003
Lead sponsor
Clalit Health Services
Responsible party
Ran Balicer (Chief Innovation Officer, Clalit Health Services, Clalit Health Services) — Principal investigator
First posted
Jan 14, 2021
Start date
Dec 23, 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Jul 20, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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