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

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Corona Virus Infection; Vaccine Effectiveness
• Intervention / Treatment: Diagnostic test: Serologic test; Diagnostic test: Respiratory swabs

• Study Type: Observational
• Enrollment (Actual): 1567

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Haemek Medical Center
  • Be'er Sheva, Israel
    • Soroka Medical Center
  • Kefar Saba, Israel
    • Meir Medical Center
  • Petach Tikva, Israel
    • Beilinson Hospital
  • Petah tikva, Israel
    • Schneider Children's Medical Center of Israel
  • Reẖovot, Israel
    • Kaplan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 vaccine effectiveness (VE)	Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months
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	18 months
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	18 months
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	18 months
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	18 months
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	18 months
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	18 months
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	18 months
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	18 months
Compartive vaccine Effectiveness of different vaccine brands	Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine	18 months

Collaborators and Investigators

• Sponsor: Clalit Health Services

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 1051-20-RMC-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No