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OpenTrials
Completed

NCT Number: NCT04709003

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

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.

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Key information

Conditions

Covid19 COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Effectiveness Virus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haemek Medical Center, Afula, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serologic test

Diagnostic Test

A blood test to check antibodies type and amount

Respiratory swabs

Diagnostic Test

PCR test to Covid-19

Primary outcomes

  1. COVID-19 vaccine effectiveness (VE)

    Time frame: 18 months

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

Secondary outcomes

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

    Time frame: 18 months

    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

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

    Time frame: 18 months

    Incidence of symptomatic SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers

  3. Duration of effectiveness of the vaccine

    Time frame: 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

  4. Vaccine Effectiveness by age

    Time frame: 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

  5. Vaccine Effectiveness by comorbidity

    Time frame: 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

  6. Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus

    Time frame: 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

  7. VE by degree of exposure to COVID-19 patients

    Time frame: 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

  8. VE by different SARS-CoV-2 variants

    Time frame: 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

  9. Vaccine effectiveness of one dose compared to two doses

    Time frame: 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

  10. Compartive vaccine Effectiveness of different vaccine brands

    Time frame: 18 months

    Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Registry information

Official study title

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

Acronym: CoVEHPI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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