Monitoring COVID-19 Vaccination Response in Fragile Populations

Summary

The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic. ORCHESTRA provides an innovative approach to learn from the pandemic SARS-CoV-2 crisis, derive recommendations to further management of COVID-19 and be prepared for the possible future pandemic waves. The ORCHESTRA project aims to deliver sound scientific evidence for the prevention and treatment of the infections caused by SARS-CoV-2 assessing epidemiological, clinical, microbiological, and genotypic aspects of population, environment and socio-economic features. The project builds upon existing, and new largescale population cohorts in Europe (France, Germany, Spain, Italy, Belgium, Romania, Netherlands, Luxemburg, and Slovakia) and non-European countries (India, Perú, Ecuador, Colombia, Venezuela, Argentina, Brazil and Gabon) including SARS-CoV-2 infected and non-infected individuals of all ages and conditions. The primary aim of ORCHESTRA is the creation of a new pan European cohort applying homogenous protocols for data collection, data sharing, sampling, and follow-up, which can rapidly advance the knowledge on the control and management of the COVID-19. ORCHESTRA will include SARS-CoV-2-negative individuals and thereby enable a prospective follow-up and an analysis of vaccination response. The cohort will involve four different populations: general population, COVID-19 patients, fragile individuals (children, elderly, transplanted, oncological, HIV infected, and those with Parkinson disease), and health-care workers. Each of these "perpetual" cohorts can answer different research questions and vaccine strategies.

Within the ORCHESTRA project, the Work Package 4 (WP4) will focus on the cohort of fragile patients including pregnant women/new-born, children, patients with HIV infection, patients with autoimmune disease, solid organ transplant recipients, patients with oncological and hematological diseases, patients with cystic fibrosis, patients with Parkinson Disease and rheumatological diseases from from 14 countries (5 European and 9 non-European countries), with approximately 20000 subjects.

Conditions

• SARS CoV 2 Infection
• Vaccination; Infection
• Breakthrough Infection

Interventions

BIOLOGICAL

COVID-19 vaccination

Monitoring COVID-19 vaccination

Sponsors & Collaborators

• Universita di Verona

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• Azienda Ulss 2 Marca Trevigiana

  collaborator OTHER

• University College Dublin

  collaborator OTHER

• Luxembourg Institute of Health

  collaborator OTHER_GOV

• Fondazione ICONA

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• University of Buenos Aires

  collaborator OTHER

• PENTA Foundation

  collaborator NETWORK

• Universiteit Antwerpen

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Helmholtz Zentrum München

  collaborator INDUSTRY

• CINECA consorzio universitario italiano

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Centre de Recherche Médicale de Lambaréné

  collaborator OTHER

• University of Bologna

  lead OTHER

Principal Investigators

• Maddalena Giannella, MD PhD · University of Bologna

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-24

Primary Completion

2023-07-16

Completion

2024-11-30

Countries

• Argentina
• Gabon
• India
• Italy
• Luxembourg
• Netherlands
• Spain

Study Locations