Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05157256

Monitoring of Anti-SARS-CoV-2 (COVID 19) and Encapsulated Vaccination Patients With Thalassemic and Falcemic Syndromes

Sponsor: Società Italiana Talassemie ed Emoglobinopatie

View on ClinicalTrials.gov

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

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