MedTrace Logo

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

NCT05157256 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-04-19

No results posted yet for this study

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.

Conditions

  • SARS-CoV-2 Infection, Thalasemmie, SCD

Sponsors & Collaborators

  • Società Italiana Talassemie ed Emoglobinopatie

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157256 on ClinicalTrials.gov