Covid19COV19HWVE_GENCT04868448
COVID-19 Vaccine Effectiveness Among Health Workers in Georgia
An observational study of Covid19, run by National Center for Disease control and Public Health at 6 sites in Georgia.
Trial summary
This is a prospective one-year cohort study of hospital-based health workers in Georgia to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Covid-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 1,600 participants
- Where
- 6 sitesGeorgia
- Study dates
- 20 Mar 2021to 1 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of health workers in the above hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. HWs include all categories of staff working in the hospitals, including clinical and non-clinical/administrative staff and staff with direct patient interaction and those without direct patient interaction. All HWs at the above hospitals who are eligible for vaccination, according to Ministry of Health guidelines, will be eligible for enrolment, regardless of their intention to receive the COVID-19 vaccine.
Who may be able to join
- All HWs eligible to receive the COVID-19 vaccination according to the national guidelines of Ministry of Health (MoH).
- HWs working at Batumi Republican Clinical Hospital, Vakhtang Bochorishvili Clinic, Academician N. Kipshidze Central University Clinic, Bokeria Tbilisi Referral Hospital, Caucasus Medical Centre, and Infectious Diseases and AIDS Center.
- HWs who have already been vaccinated with a single dose of vaccine against COVID-19 as part of the early COVID-19 vaccine rollout can be included.
Who cannot join
- HWs who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study.
- HWs who do not work at above mentioned hospitals
- HWs under 18 years of age.
- HWs who have already been vaccinated with two doses of vaccine against COVID-19 before enrolment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Georgia6 sites, 6 recruiting
- Recruiting
The Batumi Republican Clinical Hospital
Batumi, Adjara
Nana Jintcharadze, MD, +995577278729, nanajintcharadze22@gmail.com
Lia Varshalomidze, MD, +995577278728, liavarshalomidze@gmail.com
- Recruiting
The Bokeria Tbilisi Referral Hospital
Tbilisi, 0145
Nona C Beradze, MD, +995595956163, n.beradze@ncdc.ge
Rusudan Chlikadze, MD, +995595956155, r.chlikadze@ncdc.ge
- Recruiting
Academician N. Kipshidze Central University Clinic
Tbilisi, 0160
Tamar C Sulkhanishvili, MD, +995595956165, t.sulkhanishvili@ncdc.ge
Ketevan Sanadze, MD, +995595956140, k.sanadze@ncdc.ge
- Recruiting
The Bochorishvili Clinic
Tbilisi, 0160
Teona Kashibadze, MD, +995591152535, t.kashibadze@ncdc.ge
Irma Burjanadze, MD, +995595956121, i.burjanadze@ncdc.ge
- Recruiting
The Infectious Diseases and AIDS Center
Tbilisi, 0160
Teona Kashibadze, +995591152535, t.kashibadze@ncdc.ge
Irma Burjanadze, +995595956121, i.burjanadze@ncdc.ge
- Recruiting
The Caucasus Medical Centre
Tbilisi, 0186
Irina C Kalandadze, MD, +995595956151, i.kalandadze@ncdc.ge
Pikria Shavreshiani, MD, +995595424314, p.shavreshiani@ncdc.ge
About this study
Official title: Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Georgia
This is a prospective one-year cohort study of hospital-based health workers in Georgia to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease.
Read the detailed description
Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.
This is a prospective one-year cohort study of hospital-based health workers in Georgia to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease. Health Workers (HWs) are the target population in this study because they have been prioritized to be the first group to receive the vaccine in Georgia and offer an early opportunity to evaluate the vaccine in a population in which it is critical that an effective vaccine be deployed.
HWs should be enrolled after the study protocol is approved by the local ethical review committee. All HWs eligible to be vaccinated with COVID-19 vaccine can be enrolled in the study, including those who intend to get vaccinated, those who do not plan on getting vaccinated, and those who are not sure. For HWs who have already been vaccinated at enrolment, priority will be given to those who have received their first COVID vaccine no more than 4 days prior to the date of enrolment. The target enrolment is 1600 participants.
At enrolment, study participants will complete a baseline enrolment survey about demographics, clinical comorbidities, and work and community-related behaviors related to infection risk, and recent symptoms. In addition, a baseline serology will be collected from participants at enrolment.
For study participants who have not received their first COVID-19 vaccine at enrolment but receive their first vaccine 14 days or more after enrolment, an additional blood sample will be collected. In addition, a brief symptom questionnaire about recent symptoms will be administered.
During the course of the study, participants will be actively followed for suspected COVID-19 infection. Participants will be asked to complete weekly symptom questionnaires to screen for clinically significant COVID-19. Participants who meet a suspected case definition, defined according to the Georgian national case definition should provide a respiratory sample which will be collected by trained HW. Respiratory specimens will be tested for SARS-CoV-2 by RT-PCR.
All or subset of positive samples from study participants will undergo genetic sequencing, resources permitting.
Finally, after 3, 6, 9 and 12 months of the study, as resources permit, serology will be collected from participants. Serology will be tested for antibodies to SARS-CoV-2 by tests for vaccine-induced antibodies and antibodies that result from natural infection.
Vaccine effectiveness should be analysed as described in the analysis section below.
In addition to the final analysis at the end of the one-year period, interim quarterly (every three months) analyses will be undertaken.
- Conditions
- Covid19
- Being tested
- Covid-19 vaccines
- Keywords
- Vaccine effectiveness, Health workers, Georgia, Cohort study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccinesBiological
Observation of individuals who received one or more doses of covid-19 vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated participants | Participants who received 1or 2 doses of the Covid-19 vaccines Receives: Biological: Covid-19 vaccines | |
| Unvaccinated participants | Participants who have not received any dose of the Covid-19 vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 vaccine effectiveness
any SARS-CoV-2 laboratory confirmation by RT-PCR in an asymptomatic, or symptomatic patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start20 Mar 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Disease control and Public Health
- Sponsor type
- Other government
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Dr.Lia Sanodze, National Center for Disease control and Public Health
- Investigators
- Khatuna C Zakhashvili, MD, Principal investigator, National Center for Disease control and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868448
- Sponsor's protocol ID
- CERC.0097B
- Acronym
- COV19HWVE_GE
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Georgia
- ClinicalTrials.gov ID
- NCT04868448
- Acronym / sponsor ID
- COV19HWVE_GE / CERC.0097B
- Conditions
- Covid19
- Keywords
- Vaccine effectiveness, Health workers, Georgia, Cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- National Center for Disease control and Public HealthOther government
- Collaborators
- World Health Organization
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 3 May 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.
This is a prospective one-year cohort study of hospital-based health workers in Georgia to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease.
Detailed description
Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.
This is a prospective one-year cohort study of hospital-based health workers in Georgia to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease. Health Workers (HWs) are the target population in this study because they have been prioritized to be the first group to receive the vaccine in Georgia and offer an early opportunity to evaluate the vaccine in a population in which it is critical that an effective vaccine be deployed.
HWs should be enrolled after the study protocol is approved by the local ethical review committee. All HWs eligible to be vaccinated with COVID-19 vaccine can be enrolled in the study, including those who intend to get vaccinated, those who do not plan on getting vaccinated, and those who are not sure. For HWs who have already been vaccinated at enrolment, priority will be given to those who have received their first COVID vaccine no more than 4 days prior to the date of enrolment. The target enrolment is 1600 participants.
At enrolment, study participants will complete a baseline enrolment survey about demographics, clinical comorbidities, and work and community-related behaviors related to infection risk, and recent symptoms. In addition, a baseline serology will be collected from participants at enrolment.
For study participants who have not received their first COVID-19 vaccine at enrolment but receive their first vaccine 14 days or more after enrolment, an additional blood sample will be collected. In addition, a brief symptom questionnaire about recent symptoms will be administered.
During the course of the study, participants will be actively followed for suspected COVID-19 infection. Participants will be asked to complete weekly symptom questionnaires to screen for clinically significant COVID-19. Participants who meet a suspected case definition, defined according to the Georgian national case definition should provide a respiratory sample which will be collected by trained HW. Respiratory specimens will be tested for SARS-CoV-2 by RT-PCR.
All or subset of positive samples from study participants will undergo genetic sequencing, resources permitting.
Finally, after 3, 6, 9 and 12 months of the study, as resources permit, serology will be collected from participants. Serology will be tested for antibodies to SARS-CoV-2 by tests for vaccine-induced antibodies and antibodies that result from natural infection.
Vaccine effectiveness should be analysed as described in the analysis section below.
In addition to the final analysis at the end of the one-year period, interim quarterly (every three months) analyses will be undertaken.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated participants | – | Biological: Covid-19 vaccinesParticipants who received 1or 2 doses of the Covid-19 vaccines |
| Unvaccinated participants | – | –Participants who have not received any dose of the Covid-19 vaccines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of health workers in the above hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. HWs include all categories of staff working in the hospitals, including clinical and non-clinical/administrative staff and staff with direct patient interaction and those without direct patient interaction. All HWs at the above hospitals who are eligible for vaccination, according to Ministry of Health guidelines, will be eligible for enrolment, regardless of their intention to receive the COVID-19 vaccine.
Key inclusion criteria (3 listed)
- All HWs eligible to receive the COVID-19 vaccination according to the national guidelines of Ministry of Health (MoH).
- HWs working at Batumi Republican Clinical Hospital, Vakhtang Bochorishvili Clinic, Academician N. Kipshidze Central University Clinic, Bokeria Tbilisi Referral Hospital, Caucasus Medical Centre, and Infectious Diseases and AIDS Center.
- HWs who have already been vaccinated with a single dose of vaccine against COVID-19 as part of the early COVID-19 vaccine rollout can be included.
Key exclusion criteria (4 listed)
- HWs who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study.
- HWs who do not work at above mentioned hospitals
- HWs under 18 years of age.
- HWs who have already been vaccinated with two doses of vaccine against COVID-19 before enrolment
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 |
|---|---|---|
| Covid-19 vaccinesObservation of individuals who received one or more doses of covid-19 vaccines. | Biological | Vaccinated participants |
Primary outcome
Covid-19 vaccine effectiveness
Time frame: 12 months
any SARS-CoV-2 laboratory confirmation by RT-PCR in an asymptomatic, or symptomatic patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Khatuna C Zakhashvili, MD principal investigator
National Center for Disease control and Public Health
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, run by National Center for Disease control and Public Health at 6 sites in Georgia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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 Georgia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khatuna C Zakhashvili, MD (+995599317079, episurv@ncdc.ge), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 vaccine effectiveness (time frame: 12 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 3 May 2021.