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

Covid19 Clinical Trial

— CoVEHPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709003
• Other study ID #: 1051-20-RMC-C
• Status: Completed
• Start date: December 23, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2022
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1567
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Vaccine Effectiveness

Intervention

Diagnostic Test:
• Serologic test
A blood test to check antibodies type and amount
• Respiratory swabs
PCR test to Covid-19

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula
Israel	Soroka Medical Center	Be'er Sheva
Israel	Meir Medical Center	Kefar Saba
Israel	Beilinson hospital	Petach Tikva
Israel	Schneider Children's Medical Center of Israel	Petah tikva
Israel	Kaplan Medical Center	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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