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.
Study Type
OBSERVATIONAL
Enrollment
1,567
A blood test to check antibodies type and amount
PCR test to Covid-19
Haemek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Meir Medical Center
Kfar Saba, Israel
Beilinson hospital
Petah Tikva, Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
COVID-19 vaccine effectiveness (VE)
Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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
Time frame: 18 months
Compartive vaccine Effectiveness of different vaccine brands
Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with different brands of COVID-19 vaccine
Time frame: 18 months
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