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

Completed

• Conditions: Covid19; Vaccine Effectiveness; Corona Virus Infection
• Interventions: Diagnostic Test: Serologic test; Diagnostic Test: Respiratory swabs

• Registration Number: NCT04709003
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1567

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vaccinated	Respiratory swabs	participants who received the Covid-19 vaccine
unvaccinated	Serologic test	participants who didn't received the Covid-19 vaccine
vaccinated	Serologic test	participants who received the Covid-19 vaccine
unvaccinated	Respiratory swabs	participants who didn't received the Covid-19 vaccine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vaccine effectiveness of one dose compared to two doses	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
Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers	18 months	Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers
VE by different SARS-CoV-2 variants	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
Duration of effectiveness of the vaccine	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
Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus	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
Compartive vaccine Effectiveness of different vaccine brands	18 months	Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine
asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers	18 months	Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers
Vaccine Effectiveness by age	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
VE by degree of exposure to COVID-19 patients	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
Vaccine Effectiveness by comorbidity	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

Trial Locations

Locations (6)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Meir Medical Center; 🇮🇱 Kefar Saba, Israel

Haemek Medical Center; 🇮🇱 Afula, Israel

Schneider Children's Medical Center of Israel; 🇮🇱 Petah tikva, Israel

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel

Beilinson hospital; 🇮🇱 Petach Tikva, Israel