Study on COVID-19 Vaccine Effectiveness Among Health Workers in Azerbaijan (VaccEffect)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05069454 |
Recruitment Status : Unknown
Verified July 2021 by Public health and reforms Center of Ministry of Health.
Recruitment status was: Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vaccine Refusal Covid19 | Biological: COVID-19 vaccine Observation of individuals who receive the COVID-19 vaccine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1500 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Azerbaijan |
Actual Study Start Date : | May 10, 2021 |
Estimated Primary Completion Date : | May 20, 2022 |
Estimated Study Completion Date : | July 20, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Exposure group
Healthcare workers vaccinated by any of the available COVID19 vaccine;
|
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. |
Active Comparator: Control group
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
To measure the effectiveness of COVID-19 vaccines against symptomatic laboratory-confirmed SARS-CoV-2 infection amongst hospital level health workers eligible for vaccination. |
- COVID-19 vaccine effectiveness [ Time Frame: 12 months ]Weekly symptom questionnaire for all symptomatic vaccinated participants will identify potential new SARS-CoV-2 infection among vaccinated participants.
- Post-vaccination COVID-19 cases [ Time Frame: 12 months ]COVID-19 PCR testing for all symptomatic vaccinated participants will identify new SARS-CoV-2 infection among vaccinated participants.
- Vaccine effectiveness by age [ Time Frame: 12 months ]The enrollment questionnaire includes age of each participant. Data will be stratified by age at the time of analysis.
- Vaccine effectiveness in participants with various co-morbidities [ Time Frame: 12 months ]The enrollment questionnaire will assess the existence of specific co-morbidities among participants, including (but not limited to) heart disease, autoimmune disease, chronic liver disease and chronic kidney disease. Data will be stratified by co-morbidity at the time of analysis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Study Population The study population will be composed of health workers in the selected 7 hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. Health Workers 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.
Criteria
Inclusion Criteria:
- All Health Workers in selected 7 hospitals eligible to receive the COVID-19 vaccination.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069454
Azerbaijan | |
Public Health and Reforms Center of Ministry of Health | Recruiting |
Baku, Azerbaijan, AZ1122 | |
Contact: Nabil Seyidov, PhD 994503492948 nabil.seyidov@isim.az | |
Contact: Samir Mehdiyev, MPH samir.mehdiyev@isim.az | |
Principal Investigator: Gahraman Hagverdiyev, MD | |
Principal Investigator: Nabil Seyidov, PhD | |
Principal Investigator: Sabina Babazade, MD | |
Sub-Investigator: Inara Makayeva, MD | |
Sub-Investigator: Lutfi Gafarov, MD | |
Sub-Investigator: Mark Katz, MD | |
Sub-Investigator: Giorgia Gon, MD | |
Principal Investigator: Samir Mehdiyev, MPH |
Study Data/Documents: Study Protocol
Responsible Party: | Public health and reforms Center of Ministry of Health |
ClinicalTrials.gov Identifier: | NCT05069454 |
Other Study ID Numbers: |
2-PHRC-2021 |
First Posted: | October 6, 2021 Key Record Dates |
Last Update Posted: | October 6, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |