Covid19CoVEHPINCT04709003
Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)
An observational study of Covid19 and Corona Virus Infection, run by Clalit Health Services at 6 sites in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Corona Virus Infection, Vaccine Effectiveness
- What is being tested?
- Serologic test and Respiratory swabs
- Type of treatment
- Vaccines
- How many people
- 1,567 participants
- Where
- 6 sitesIsrael
- Study dates
- 23 Dec 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir, Beilinson, HaEmek, and Schneider)
Who may be able to join
- 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
Who cannot join
- -
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
Haemek Medical Center
Afula
Soroka Medical Center
Beersheba
Meir Medical Center
Kfar Saba
Beilinson hospital
Petah Tikva
Schneider Children's Medical Center of Israel
Petah Tikva
Kaplan Medical Center
Rehovot
About this study
Official title: Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study
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
- Being tested
- Serologic test, Respiratory swabs
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serologic testDiagnostic test
A blood test to check antibodies type and amount
Respiratory swabsDiagnostic test
PCR test to Covid-19
| Study group | Role | What they receive |
|---|---|---|
| vaccinated | participants who received the Covid-19 vaccine Receives: Diagnostic Test: Serologic test; Diagnostic Test: Respiratory swabs | |
| unvaccinated | participants who didn't received the Covid-19 vaccine Receives: Diagnostic Test: Serologic test; Diagnostic Test: Respiratory swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccine effectiveness (VE)
Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers
Measured: 18 months
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start23 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Balicer, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709003
- Sponsor's protocol ID
- 1051-20-RMC-C
- Acronym
- CoVEHPI
- Status last verified
- Jul 2022
- First submitted
- 6 Jan 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04709003
- Acronym / sponsor ID
- CoVEHPI / 1051-20-RMC-C
- Conditions
- Covid19, Corona Virus Infection, Vaccine Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,567 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated | – | Diagnostic Test: Serologic test, Diagnostic Test: Respiratory swabsparticipants who received the Covid-19 vaccine |
| unvaccinated | – | Diagnostic Test: Serologic test, Diagnostic Test: Respiratory swabsparticipants who didn't received the Covid-19 vaccine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir, Beilinson, HaEmek, and Schneider)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- -
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serologic testA blood test to check antibodies type and amount | Diagnostic test | unvaccinated, vaccinated |
| Respiratory swabsPCR test to Covid-19 | Diagnostic test | unvaccinated, vaccinated |
Primary outcome
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
10 secondary outcomes
Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers
Time frame: 18 months
asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers
Time frame: 18 months
Duration of effectiveness of the vaccine
Time frame: 18 months
Vaccine Effectiveness by age
Time frame: 18 months
Vaccine Effectiveness by comorbidity
Time frame: 18 months
Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus
Time frame: 18 months
VE by degree of exposure to COVID-19 patients
Time frame: 18 months
VE by different SARS-CoV-2 variants
Time frame: 18 months
Vaccine effectiveness of one dose compared to two doses
Time frame: 18 months
Compartive vaccine Effectiveness of different vaccine brands
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Corona Virus Infection, run by Clalit Health Services at 6 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccine effectiveness (VE) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.