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

NCT ID: NCT04709003

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-23

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Covid19 Corona Virus Infection Vaccine Effectiveness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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vaccinated

participants who received the Covid-19 vaccine

Serologic test

Intervention Type DIAGNOSTIC_TEST

A blood test to check antibodies type and amount

Respiratory swabs

Intervention Type DIAGNOSTIC_TEST

PCR test to Covid-19

unvaccinated

participants who didn't received the Covid-19 vaccine

Serologic test

Intervention Type DIAGNOSTIC_TEST

A blood test to check antibodies type and amount

Respiratory swabs

Intervention Type DIAGNOSTIC_TEST

PCR test to Covid-19

Interventions

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Serologic test

A blood test to check antibodies type and amount

Intervention Type DIAGNOSTIC_TEST

Respiratory swabs

PCR test to Covid-19

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Ran Balicer

Chief Innovation Officer, Clalit Health Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haemek Medical Center

Afula, , Israel

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Beilinson hospital

Petah Tikva, , Israel

Site Status

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Countries

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Israel

Other Identifiers

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1051-20-RMC-C

Identifier Type: -

Identifier Source: org_study_id

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