Clinical trial NCT04709003: Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)
Official title: Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Corona Virus Infection
Vaccine Effectiveness
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 1567
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir, Beilinson, HaEmek, and Schneider)

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.


Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 vaccine effectiveness (VE)
timeFrame: 18 months
Secondary outcomes:
measure: Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers
timeFrame: 18 months
measure: asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers
timeFrame: 18 months
measure: Duration of effectiveness of the vaccine
timeFrame: 18 months
measure: Vaccine Effectiveness by age
timeFrame: 18 months
measure: Vaccine Effectiveness by comorbidity
timeFrame: 18 months
measure: Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus
timeFrame: 18 months
measure: VE by degree of exposure to COVID-19 patients
timeFrame: 18 months
measure: VE by different SARS-CoV-2 variants
timeFrame: 18 months
measure: Vaccine effectiveness of one dose compared to two doses
timeFrame: 18 months
measure: Compartive vaccine Effectiveness of different vaccine brands
timeFrame: 18 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Kefar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Beilinson hospital
city: Petah tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References: