NCT05157256

Brief 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. 1.Evaluate the appearance, extent, and duration of humoral response (antibodies) to the anti-SARS-CoV-2 vaccine;
  2. 2.Assess the incidence of positive cases after vaccination.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2022Dec 2030

First Submitted

Initial submission to the registry

December 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

9 years

First QC Date

December 10, 2021

Last Update Submit

April 18, 2023

Conditions

SARS-CoV-2 Infection, Thalasemmie, SCD

Outcome Measures

Primary Outcomes (4)

  • Evaluate the appearance, extent, and duration of humoral response (antibodies) to the anti-SARS-CoV-2 vaccine;

    through study completion, an average of 1 year

  • Assess the incidence of positive cases after vaccination.

    through study completion, an average of 1 year

  • - 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

    through study completion, an average of 1 year

  • Evaluate the presence and extent of the response to previous vaccinations to encapsulated bacteria.

    through study completion, an average of 1 year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with TDT and SCD.

You may qualify if:

  • Main study and first substudy:
  • Patients with advancedTDT and SCD diagnosis, age \> 18 years
  • signature of informed consent.
  • Second substudy:
  • Splenectomized patients withTDT and SCD diagnosed, age \> 18 years
  • signature of informed consent.

You may not qualify if:

  • No signature informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano, Torino, Italia

Torino, TO, Italy

Location

Azienda Ospedaliera Universitaria Di Cagliari

Cagliari, 09121, Italy

Location

Day Hospital della Talassemia e delle Emoglobinopatie - A.O.U. di Ferrara - Nuovo Ospedale S.Anna - Sede di Cona

Ferrara, Italy

Location

Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro

Genova, 16128, Italy

Location

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Location

Department of Women, Children and General and Specialist Surgery AOU-- University of Campania "Luigi Vanvitelli

Napoli, Italy

Location

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

Location

Dipartimento OncoEmatologia, Terapia Cellulare, Terapie Geniche e Trapianto Emopoietico

Roma, Italy

Location

Policlinico G.B. Rossi

Verona, 37122, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 14, 2021

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations

IT(9)