Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)

Обзор

The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).

Подробное описание

Background: Protection from SARS-CoV-2 infection is known to occur soon after vaccination or natural disease, fading over time. Although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. Recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. Study objectives: The EuCARE-HCW study contributes with data and samples from

HCW to EuCARE-IMMUNITY study that will analyse the NtAb and CMI to different SARS- CoV-2 variants following any combination of natural infection and vaccination. Specific

objectives include:

* to collect data and biological material from COVID-19 healthcare workers in 9 clinics from 8 countries and 3 continents. * Enrolment of HCW with an immunogenic event, either vaccination or infection. * Periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists). * Sample preparation, storage and shipment to central EuCARE laboratories where WP2 study group will analyse natural and artificial immunity to SARS-CoV-2 variants (EuCARE-IMMUNITY), namely:

* Analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination. * Define the cross-immunity among the different viral variants. * Analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s). * To accomplish the above objectives, WP2 will test:

* Neutralising antibodies * Cellular immunity * Viral sequences

Вмешательства

• Другое Follow up of the first known immunization event
  The baseline for enrolment into the study is defined by the occurrence of the first known immunization event, either natural infection or vaccination. The follow-up is planned to last 24 months with respect to this baseline. In subjects with natural infection, the viral variant must be determined for each prospective case by analysis of a nasopharyngeal swab obtained as soon as possible at diagnosis. For historical cases where the variant was not determined and a contemporary nasopharyngeal swab

Первичные конечные точки

• Number of HCW involved in the study [Срок оценки: through study completion, an average of 3 years]

Критерии участия

Критерии включения

The study subjects will be selected based on the following inclusion criteria:

• Adult (>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status.
• For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
• Having a signed informed consent when required by ethical approval

Exclusion Criteria: NONE

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo — Milan
• Ieo Istituto Europeo Di Oncologia — Milan

Германия · 1 центр

• Heinrich Heine university — Düsseldorf

Литва · 1 центр

• Viesoji Istaiga Vilniaus Uiversiteto Ligoninė Santaros klinikos — Vilnius

Мексика · 1 центр

• Hospital Juan Ghaham Casasus — Villahermosa

Португалия · 1 центр

• Centro Hospitalar de Lisboa Ocidental — Lisbon

Вьетнам · 1 центр

• Bach Mai Hospital — Hanoi

Идентификаторы

NCT: NCT05534009 · EuCARE-HCW

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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