Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05069454 |
| Other study ID # |
2-PHRC-2021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
July 20, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Public health and reforms Center of Ministry of Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
2. Background and study rationale In late 2019 a novel severe acute respiratory syndrome -
coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), emerged. On
January 30, 2020, WHO declared COVID-19 a public health emergency of international concern.
On 11 March 2020, the World Health Organization declared COVID-19 a pandemic. The first case
of COVID-19 was detected in Azerbaijan end of February, 2020, and since then 236,012 cases
and 3,235 deaths has been reported in the country (data as of 8 March 2021).1
Effective and safe vaccines against COVID-19 are vital for controlling the pandemic.
International collaborative efforts have accelerated the development of COVID-10 vaccines. As
of 5 March 2021, there were 182 vaccines in pre-clinical development, and 79 vaccines in
clinical development2. As of 18 February 2021, at least seven different vaccines across three
platforms had been rolled out in countries, including the Coronac vaccine produced by Chinese
company Sinopharm.
Evaluating the real-world COVID-19 vaccine performance is critical for understanding the
risks and benefits of vaccination programs. Many factors impact real-world vaccine
effectiveness (VE), including vaccine transportation and storage and how patients are
vaccinated. In addition, the people who get the vaccine in clinical trials are often young
and healthy, and therefore different from those who will receive vaccines in the real world.
Post-licensing VE studies can also answer questions about effectiveness by age-group and
underlying medical conditions, duration of vaccine protection, relative effectiveness of
different vaccines, relative effectiveness of one dose vs. two doses, and effectiveness of
the vaccine against new strains of SARS-CoV-2.
Health workers (HW) have been targeted for this study for a number of reasons. Azerbaijan has
prioritized HWs for vaccination in line with the recommendations of the WHO SAGE and the
European Technical Advisory Group on immunizations for use of COVID-19 vaccines when supply
is limited. HWs provide a critical essential service in the COVID-19 pandemic response. HWs
are at high risk of acquiring infection and associated morbidity and mortality, and also pose
a risk of onward transmission to people who are also at high risk of serious COVID-19
outcomes. Ensuring that HWs receive an effective vaccine is also guided by the principle of
reciprocity because HWs play critical roles in the COVID-19 response, working under intense
and challenging conditions. Targeting HWs in this study offers an opportunity to determine
the effectiveness of the vaccine in a population in which it is critical that an effective
vaccine be deployed. While the HW population is not perfectly representative of the
population of Azerbaijan, having an early understanding of the effectiveness of the vaccine
in this population can inform decisions about vaccine use in the general population.
Immunization of HWs in Azerbaijan with Coronavac started in January 18, and the second dose
has been administered to more than 60% of HWs by 15 March 2021. At the same time, it is
estimated that 45-60% of health workers at the six target hospitals have received at least
one dose and 60% of those have also received second dose of the vaccine.
Investigators propose to study the effectiveness of the COVID-19 vaccine in HWs in six
selected hospitals in Baku city of Azerbaijan in order to answer critical questions about the
real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.
The stakeholders of this study include the following: Azerbaijan Republic Ministry of Health,
The Public Health and Reforms Center of the Azerbaijan MOH, TABIB (which is subsidiary of
Mandatory Health Insurance Agency of Azerbaijan that manages most hospitals in the country)
health workers in the six hospitals and in Azerbaijan in general, the administration of the
six study hospitals, and the World Health Organization.
2.1. Objectives 2.1.1. Primary objective To measure the effectiveness of COVID-19 vaccines
against symptomatic laboratory-confirmed SARS-CoV-2 infection amongst hospital level health
workers eligible for vaccination.
2.1.2. Secondary objectives
- What is the effectiveness of Covid-19 vaccine in preventing any laboratory- confirmed
SARS-CoV-2 infection, including symptomatic and asymptomatic infection, as measured by
infection detected by PCR and serology?
- How long does the COVID-19 vaccine confer protection against infection?
- What is vaccine effectiveness (VE) by age?
- What is VE by comorbidity?
- What is the VE in people who have been previously infected with SARS-CoV-2 compared with
those who were previously uninfected?
- Does vaccine effectiveness vary by degree of exposure to COVID-19 patients in the
hospital setting and physical distancing practices outside of the hospital?
- Does vaccine effectiveness vary by new strains of SARS-CoV-2 that may emerge?
3. Methods 3.1. Study setting and population
The study will be conducted among health workers working in six hospitals in different
districts of Baku, the capital of Azerbaijan republic. The number of employees in each
hospital is provided in the Table below.
Hospitals in Baku are chosen for a number of reasons. The Baku capital is the largest city in
the country with over 3 million inhabitants. It has the largest hospitals in the country and
the largest number of hospital-based HWs of any city in the country. Baku has been and still
is at the forefront of fight with pandemic; the largest number of infections have occurred in
Baku, and the largest number of COVID-19 patients requiring medical care are being treated in
Baku hospitals. In addition, conducting the study in Baku will facilitate issues related to
monitoring, supervision and logistics,. given the nation-wide quarantine-related restrictions
and limitations to regional travel. Investigators selected a convenience samples of hospitals
in various parts of Baku city.
The study population will be composed of HWs in the above hospitals, eligible for
vaccination, with no contraindication to receive COVID-19 vaccine. HWs include all categories
of staff working in these hospitals, including clinical and non-clinical/administrative staff
and staff with direct patient interaction and those without direct patient interaction.
All HWs who are eligible for vaccination, according to MoH guidelines, will be offered
enrolment, regardless of their intention to receive the COVID-19 vaccine. Currently, all HWs
are eligible to receive vaccines unless they have contraindications, such as severe allergic
reactions to previous vaccinations. Along with HWs, the educators, police and military
personnel as well as all citizens >50 years of age are eligible to receive vaccines unless
there are contraindications including allergies to vaccine incipient/excipients or previously
confirmed allergic reaction to vaccination or current viral or bacterial infections.
This study will ensure follow up of enrolled participants via serology, respiratory swabs,
and questionnaires. Participants may receive COVID19 vaccine during the study period but not
as part of this study.
Efforts will be made to enroll all HW as close as possible to the time of their first
vaccination.
Study staff will coordinate with hospital administration in order to ensure that the study
will not interfere with vaccine administration.
