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

Clalit Health Services

Status

Completed

Conditions

Corona Virus Infection

Vaccine Effectiveness

Covid19

Treatments

Diagnostic Test: Serologic test

Diagnostic Test: Respiratory swabs

Study type

Observational

Funder types

Other

Identifiers

NCT04709003

1051-20-RMC-C

Details and patient eligibility

About

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.

Enrollment

1,567 patients

Sex

All

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

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