COVID-19 Vaccine Effectiveness Among Health Workers in Georgia

NCT04868448 | Unknown

• 1 other identifier: CERC.0097B
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Covid19

Keywords

Vaccine effectiveness; Health workers; Georgia; Cohort study

Outcome Measures

Primary Outcomes (1)

• Covid-19 vaccine effectiveness

  any SARS-CoV-2 laboratory confirmation by RT-PCR in an asymptomatic, or symptomatic patient

  12 months

Study Arms (2)

Vaccinated participants

Participants who received 1or 2 doses of the Covid-19 vaccines

Biological: Covid-19 vaccines

Unvaccinated participants

Participants who have not received any dose of the Covid-19 vaccines

Interventions

Covid-19 vaccines BIOLOGICAL

Observation of individuals who received one or more doses of covid-19 vaccines.

Vaccinated participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Disease control and Public Health: lead
• World Health Organization: collaborator

Study Sites (6)

The Batumi Republican Clinical Hospital

Batumi, Adjara, Georgia

RECRUITING

The Bokeria Tbilisi Referral Hospital

Tbilisi, 0145, Georgia

RECRUITING

Academician N. Kipshidze Central University Clinic

Tbilisi, 0160, Georgia

RECRUITING

The Bochorishvili Clinic

Tbilisi, 0160, Georgia

RECRUITING

The Infectious Diseases and AIDS Center

Tbilisi, 0160, Georgia

RECRUITING

The Caucasus Medical Centre

Tbilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Khatuna C Zakhashvili, MD

  National Center for Disease control and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khatuna C Zakhashvili, MD

CONTACT

+995599317079; episurv@ncdc.ge

Lia Sanodze, MD

CONTACT

+995595993804; l.sanodze@ncdc.ge

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 3, 2021
• Study Start: March 20, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6)