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

NCT05069454 | Unknown DMC

• 1 other identifier: 2-PHRC-2021
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• COVID-19 vaccine effectiveness

  Weekly symptom questionnaire for all symptomatic vaccinated participants will identify potential new SARS-CoV-2 infection among vaccinated participants.

  12 months

• Post-vaccination COVID-19 cases

  COVID-19 PCR testing for all symptomatic vaccinated participants will identify new SARS-CoV-2 infection among vaccinated participants.

  12 months

Secondary Outcomes (2)

• Vaccine effectiveness by age

  12 months

• Vaccine effectiveness in participants with various co-morbidities

  12 months

Study Arms (2)

Exposure group

ACTIVE COMPARATOR

Healthcare workers vaccinated by any of the available COVID19 vaccine;

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

Control group

ACTIVE COMPARATOR

Have not received any doses of any form of COVID-19 vaccine

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

Interventions

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

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

Control group; Exposure group

Eligibility Criteria

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

You may qualify if:

• \- All Health Workers in selected 7 hospitals eligible to receive the COVID-19 vaccination.

You may not qualify if:

• Health Workers who are not eligible for COVID-19 vaccination or have a contraindication to vaccination.
• Health Workers who do not work at selected 7 hospitals.

Sponsors & Collaborators

• Public health and reforms Center of Ministry of Health: lead
• World Health Organization: collaborator
• Ministry of Health of Azerbaijan Republic: collaborator

Study Sites (1)

Public Health and Reforms Center of Ministry of Health

Baku, AZ1122, Azerbaijan

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Vaccination Refusal; COVID-19

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective longitudinal cohort study, which will compare SARS-CoV-2 incidence among COVID-19 vaccinated and unvaccinated HWs who are eligible for COVID-19 vaccination in Azerbaijan. Upon approval of the protocol, all HWs working at six hospitals of Baku capital and who are eligible for COVID-19 vaccination will be offered to participate in the study and followed up regularly over time. The participation is completely voluntary.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: October 6, 2021
• Study Start: May 10, 2021
• Primary Completion: May 20, 2022
• Study Completion: July 20, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-07

Locations

AZ (1)