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

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ClinicalTrials.gov Identifier: NCT04709003
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ran Balicer, Clalit Health Services

Brief 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.

Condition or disease Intervention/treatment
Covid19 Corona Virus Infection Vaccine Effectiveness Diagnostic Test: Serologic test Diagnostic Test: Respiratory swabs

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Study Type : Observational
Estimated Enrollment : 4504 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
vaccinated
participants who received the Covid-19 vaccine
Diagnostic Test: Serologic test
A blood test to check antibodies type and amount

Diagnostic Test: Respiratory swabs
PCR test to Covid-19

unvaccinated
participants who didn't received the Covid-19 vaccine
Diagnostic Test: Serologic test
A blood test to check antibodies type and amount

Diagnostic Test: Respiratory swabs
PCR test to Covid-19




Primary Outcome Measures :
  1. COVID-19 vaccine effectiveness (VE) [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers


Secondary Outcome Measures :
  1. Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers [ Time Frame: 18 months ]
    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

  2. asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers [ Time Frame: 18 months ]
    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

  3. Duration of effectiveness of the vaccine [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers over different periods of time

  4. Vaccine Effectiveness by age [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers of different age groups

  5. Vaccine Effectiveness by comorbidity [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers by various underly medical conditions

  6. Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in previously infection healthcare workers vaccinated with COVID-19 vaccine compared to previously infection unvaccinated healthcare workers

  7. VE by degree of exposure to COVID-19 patients [ Time Frame: 18 months ]
    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

  8. VE by different SARS-CoV-2 variants [ Time Frame: 18 months ]
    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

  9. Vaccine effectiveness of one dose compared to two doses [ Time Frame: 18 months ]
    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

  10. Compartive vaccine Effectiveness of different vaccine brands [ Time Frame: 18 months ]
    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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:

-

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

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): NCT04709003


Contacts
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Contact: Mili Yacobi 972523615789 miliya@clalit.org.il
Contact: Avital Hirsch, MPH 972523873981 avitalhi@clalit.org.il

Locations
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Israel
Haemek Medical Center Recruiting
Afula, Israel
Contact: Hana Edelstein    9726495520    hana_e@clalit.org.il   
Principal Investigator: Bibiana Chazan, MD         
Soroka Medical Center Recruiting
Be'er Sheva, Israel
Contact: Orly Zamir    972522880220    OrlyBZ@clalit.org.il   
Principal Investigator: David Greenberg, MD         
Meir Medical Center Recruiting
Kefar Saba, Israel
Contact: Galit Carmon    97297472280    galit.carmon@clalit.org.il   
Principal Investigator: Michal Chowers, MD         
Beilinson hospital Recruiting
Petach Tikva, Israel
Contact: Alon Peretz, MD    972523236763    SHalonpe@clalit.org.il   
Principal Investigator: Alon Peretz, MD         
Schneider Children's Medical Center of Israel Recruiting
Petah tikva, Israel
Contact: Dana Reznik    972526211059    danaa3@clalit.org.il   
Principal Investigator: Efrat Baron Har-Lev, MD         
Kaplan Medical Center Recruiting
Reẖovot, Israel
Contact: Sagi Tzhori, MD    97289440674    sagitz1@clalit.org.il   
Principal Investigator: Sagi Tzhori, MD         
Sponsors and Collaborators
Clalit Health Services
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Responsible Party: Ran Balicer, Chief Innovation Officer, Clalit Health Services, Clalit Health Services
ClinicalTrials.gov Identifier: NCT04709003    
Other Study ID Numbers: 1051-20-RMC-C
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections