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

NCT04709003 | Completed DMC

• 1 other identifier: 1051-20-RMC-C
• Study Type: observational
• Target: 1,567
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid19; Corona Virus Infection; Vaccine Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers

  18 months

• asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers

  18 months

• Duration of effectiveness of the vaccine

  18 months

• Vaccine Effectiveness by age

  18 months

• Vaccine Effectiveness by comorbidity

  18 months

Study Arms (2)

vaccinated

participants who received the Covid-19 vaccine

Diagnostic Test: Serologic test; Diagnostic Test: Respiratory swabs

unvaccinated

participants who didn't received the Covid-19 vaccine

Diagnostic Test: Serologic test; Diagnostic Test: Respiratory swabs

Interventions

Serologic test DIAGNOSTIC_TEST

A blood test to check antibodies type and amount

unvaccinated; vaccinated

Respiratory swabs DIAGNOSTIC_TEST

PCR test to Covid-19

unvaccinated; vaccinated

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (6)

Haemek Medical Center

Afula, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Beilinson hospital

Petah Tikva, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Innovation Officer, Clalit Health Services

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 14, 2021
• Study Start: December 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

IL (6)