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Study on COVID-19 Vaccine Effectiveness Among Health Workers in Azerbaijan

NCT05069454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2021-10-06

No results posted yet for this study

Summary

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 protocol describes a prospective one-year cohort study of hospital-based HWs in Baku city of Azerbaijan to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID-19 disease. HWs are the target population in this study because HWs have been prioritized to be the first group to receive the vaccine in Azerbaijan and offer an early opportunity to evaluate the vaccine in a population in which it is critical that an effective vaccine be deployed.

HWs will 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 don't plan on getting vaccinated, and those who are not sure. The target enrolment is 1500 HWs in six hospitals in Baku, the capital of Azerbaijan.

At enrolment, study participants will complete a baseline enrolment e-survey about demographics, clinical comorbidities, and work- and community-related behaviours related to infection risk. In addition, a baseline serology will be collected from participants at enrolment. No PCR testing for COVID19 virus will be done at the time of enrollment.

During the course of the study, participants will be actively followed for suspected symptomatic COVID-19 illness. Participants who meet a suspected case definition will be asked to have respiratory sample for SARS-CoV-2 by RT-PCR to be collected by trained HWs. PCR-positive samples from participants may also undergo genetic sequencing in or outside of Azerbaijan to identify the genetic makeup of the SARS-CoV-2 that caused the infection.

Finally, at 6 months and 12 months of the study, serology will be collected from participants to confirm and quantify the immunity after vaccination as a secondary objective. Serology will be tested for antibodies to SARS-CoV-2. Serology samples will be stored and may be sent to laboratories outside of Azerbaijan for advanced serologic testing.

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

  • Vaccine Refusal
  • Covid19

Interventions

BIOLOGICAL

COVID-19 vaccine Observation of individuals who receive the COVID-19 vaccine

To measure the effectiveness of COVID-19 vaccines against symptomatic laboratory-confirmed SARS-CoV-2 infection amongst hospital level health workers eligible for vaccination.

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Ministry of Health of Azerbaijan Republic

    collaborator UNKNOWN

  • Public health and reforms Center of Ministry of Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-05-20
Completion
2022-07-20

Countries

  • Azerbaijan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069454 on ClinicalTrials.gov