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Monitoring of Anti-SARS-CoV-2 (COVID 19) and Encapsulated Vaccination Patients With Thalassemic and Falcemic Syndromes
Sponsor: Società Italiana Talassemie ed Emoglobinopatie
Summary
There is an urgent need to rapidly evaluate anti-Covid 19 vaccination treatments, in terms of immune response (humoral and cell-mediated) together with the verification of the effectiveness of the vaccine in preventing SARS-CoV-2 infection in thalassemic subjects. It is also necessary to increase scientific knowledge in order to improve clinical practice to have presence responses and maintenance extent of the response to vaccinations against encapsulated bacteria carried out previously. The objectives of the main study are: 1. Evaluate the appearance, extent, and duration of humoral response (antibodies) to the anti-SARS-CoV-2 vaccine; 2. Assess the incidence of positive cases after vaccination. The objective of the first sub-study is: \- Evaluate the appearance, extent, and duration of cellular response (T lymphocytes and B lymphocytes) to the anti-SARS-CoV-2 vaccine based on age groups and the presence/absence of hypo/asplenia. The objective of the second sub-study is: \- Evaluate the presence and extent of the response to previous vaccinations to encapsulated bacteria.
Official title: Monitoring of Anti-SARS-CoV-2 (COVID 19) and Encapsulated Vaccination in a Cohort of Patients With Thalassemic and Falcemic Syndromes
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2022-01-01
Completion Date
2030-12-31
Last Updated
2023-04-19
Healthy Volunteers
Yes
Conditions
Locations (9)
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano, Torino, Italia
Torino, TO, Italy
Azienda Ospedaliera Universitaria Di Cagliari
Cagliari, Italy
Day Hospital della Talassemia e delle Emoglobinopatie - A.O.U. di Ferrara - Nuovo Ospedale S.Anna - Sede di Cona
Ferrara, Italy
Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
Genova, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
Department of Women, Children and General and Specialist Surgery AOU-- University of Campania "Luigi Vanvitelli
Naples, Italy
U.O.C. di Ematologia e Malattie Rare del Sangue e degli Organi Ematopoietici - Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello" - Presidio Cervello
Palermo, Italy
Dipartimento OncoEmatologia, Terapia Cellulare, Terapie Geniche e Trapianto Emopoietico
Roma, Italy
Policlinico G.B. Rossi
Verona, Italy