Monitoring COVID-19 Vaccination Response in Fragile Populations (ORCHESTRA-4)
"Multicenter Observational Study to Assess the Incidence and Features of COVID-19 and the Response to COVID-19 Vaccination in Fragile Patients"
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Since the beginning of COVID-19 pandemic, several special settings have been identified regarding the susceptibility to SARS-CoV-2 infection, the associated clinical spectrum and outcome. The participants include pregnant women, pediatric patients, elderly in particular those whole live in long-term care facilities (LTCFs), and immunocompromised hosts including solid organ transplant recipients (SOT), hematopoietic stem cell transplant (HSCT) recipients and patients with cancer. Among pregnant women and children, asymptomatic or mild diseases have been frequently reported, prompting controversial concerns about their role in the infection transmission in community and hospital settings.
On the other hand, a high impact of COVID-19 on morbidity and mortality has been described in elderly and immuno-compromised hosts. Thus, optimization of prevention strategies, screening practices and therapeutic management is strongly advocated in fragile patients. Indeed, these settings have been established as priority groups for vaccines. However, safety and efficacy of vaccination in these populations should be carefully assessed. Thus, preliminary epidemiological data are strongly needed to design further intervention trials and health policies.
Besides, an increasing body of evidence suggests that the gut microbiota plays a role in determining the severity of COVID-19, possibly through the modulation of immune responses. Furthermore, dysbiosis of the gut microbiota could contribute to the persistence of symptoms, even after the resolution of the disease.
For the same reasons, the microbiota could be involved in the onset of adverse reactions induced by vaccination, especially in fragile populations, as recently discussed. Defining the impact of the microbiota on immunity to vaccination and therefore on its effectiveness is currently considered a priority in various clinical settings.
Moreover, early observations show that vaccines do not induce an immune response conferring protection to many fragile patients, resulting in severe Covid-19 cases. It is important to understand what cellular networks and molecular pathways are switched on/off by the administration of vaccines, and to identify the biological patterns that characterize responders and non-responders. DNA methylation and gene expression analyses may inform on the genomic patterns involved in response to vaccines and in the differences between responders and non-responders. Indeed, DNA sequencing may reveal that the perturbation detected at the regulatory levels may be influenced by alterations in the genome of the divergent subjects.
With this premise, the Investigators deem that a WP dedicated to fragile patients in the ORCHESTRA project is necessary to inform about the peculiarities of the fragile cohort as a whole, and of each subgroup as well, providing clinical and biological information useful to design targeted prevention and therapeutic strategies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Universidad de Buenos Aires (UBA)
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Lambaréné, Gabon
- Centre de Recherches Médicales de Lambaréné (CERMEL)
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Bangalore, India
- Catholics Bishops Conference of India, Society for Medical Education (CBCI)
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Faridabad, India
- Translational Health Science and Technology Institute (THSTI)
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Bologna, Italy
- University of Bologna
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Milano, Italy
- ICONA Foundation
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Padova, Italy
- PENTA Foundation
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Padova, Italy
- Aziena Ospedaliera Universitaria di Padova - Centro Trapianti di fegato
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Padova, Italy
- Azienda Ospedaliera Universitaria di Padova - Centro trapianti di polmone
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Padova, Italy
- Azienda Ospedaliera Universitaria di Padova - UOC Chirurgia dei trapianti di rene
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Padova, Italy
- Azienda Ospedaliera Universitaria di Padova - UOC Nefrologia Pediatrica
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Padova, Italy
- Azienda Ospedaliero Universitaria di Padova - Clinica Medica 5
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Padova, Italy
- Azienda Ospedaliero Universitaria di Padova - Trapianto Multiviscerale
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Padova, Italy
- Azienda Ospedaliero Universitaria di Padova - UOC Cardiochirurgia
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Padova, Italy
- Azienda Ospedaliero Universitaria di Padova - UOC Clinica Pediatrica
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Treviso, Italy
- Azienda ULSS2 Marca Trevigiana
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Verona, Italy
- University of Verona
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Luxembourg, Luxembourg
- Luxembourg Institute of Health (LIH)
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Groningen, Netherlands
- University Medical Center Groningen (UMCG)
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Sevilla, Spain
- Hosp. Univ. Virgen Macarena / Universidad de Sevilla
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any age
- Any comorbidity
- Person (or attorney or deputy who has been authorized to make the decision for patients who lack capacity) consent to participate or appropriate local waiver of consent.
Exclusion Criteria:
- Patients did not agree to participate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Solid organ transplant recipients
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Monitoring COVID-19 vaccination
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Patients with oncological diseases
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Monitoring COVID-19 vaccination
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Patients with hematological diseases
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Monitoring COVID-19 vaccination
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Patients with cystic fibrosis
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Monitoring COVID-19 vaccination
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Patients with Parkinson Disease
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Monitoring COVID-19 vaccination
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Patients with rheumatological diseases
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Monitoring COVID-19 vaccination
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Pregnant women/ New-borns
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Monitoring COVID-19 vaccination
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Children
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Monitoring COVID-19 vaccination
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People living with HIV
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Monitoring COVID-19 vaccination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Early immune response to COVID-19 vaccine patients
Time Frame: 3 ± 1 month after vaccination onset
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To investigate the early immune response to COVID-19 vaccine in fragile patients assessing the levels of antibodies against Spike antigens and the patterns of cellular immune response
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3 ± 1 month after vaccination onset
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Late immune response to COVID-19 vaccine
Time Frame: 12 ± 3 months after vaccination onset
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To investigate the late immune response to COVID-19 vaccine in fragile patients assessing the levels of antibodies against Spike antigens and the patterns of cellular immune response
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12 ± 3 months after vaccination onset
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Rate of COVID-19 breakthrough infections
Time Frame: within 1 year after vaccination onset
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To investigate the rate of COVID-19 breakthrough infections in fragile patients within 1 year after vaccination onset
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within 1 year after vaccination onset
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Rate of hospital admission for COVID-19 breakthrough infections condition and its impact on the outcome in fragile patients
Time Frame: within 1 year after vaccination onset
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To investigate the rate of hospital admission for COVID-19 breakthrough infections in fragile patients
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within 1 year after vaccination onset
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Rate of death for COVID-19 breakthrough infections patients
Time Frame: within 1 year after vaccination onset
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To investigate the rate of death for COVID-19 breakthrough infections in fragile patients
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within 1 year after vaccination onset
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maddalena Giannella, MD PhD, University of Bologna
Publications and helpful links
Helpful Links
- SARS-CoV-2 vaccination in solid-organ transplant recipients: What the clinician needs to know.
- Evaluation of the kinetics of antibody response to COVID-19 vaccine in solid organ transplant recipients: the prospective, multicenter ORCHESTRA cohort.
- Relationship Between Immune Response to Severe Acute Respiratory Syndrome Coronavirus 2 Vaccines and Development of Breakthrough Infection in Solid Organ Transplant Recipients: The CONTRAST Cohort
- Effect of a Fourth Dose of mRNA Vaccine and of Immunosuppression in Preventing SARS-CoV-2 Breakthrough Infections in Heart Transplant Patients.
- Using machine learning to predict antibody response to SARS-CoV-2 vaccination in Solid Organ Transplant Recipients. The multicentre ORCHESTRA cohort.
- SARS-CoV-2 mRNA Vaccine Response in People Living with HIV According to CD4 Count and CD4/CD8 Ratio.
- SARS-CoV-2 mRNA vaccination and short-term changes in viral load and CD4/CD8 T-cell counts in people living with HIV
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Breakthrough Infections
- Infections
- Communicable Diseases
Other Study ID Numbers
- ORCHESTRA-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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