NCT05157256: HEMOGLOB-VAX

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

Active, enrolled Last updated 19 April 2023

What this trial tests

trial in SARS-CoV-2 Infection, Thalasemmie, SCD in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2022

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	Società Italiana Talassemie ed Emoglobinopatie
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 January 2022
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	9 locations across Italy

Conditions studied

• SARS-CoV-2 Infection, Thalasemmie, SCD — all drugs for SARS-CoV-2 Infection, Thalasemmie, SCD →

Sponsor

Società Italiana Talassemie ed Emoglobinopatie — full company profile →

Who can join

Eligibility, any sex, with SARS-CoV-2 Infection, Thalasemmie, SCD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Premature aging of the immune system affects the response to SARS-CoV-2 mRNA vaccine in β-thalassemia: role of an additional dose.
   Carsetti R, Agrati C, Pinto VM, Gianesin B, et al · · 2022 · cited 13× · PMID 36004936 · DOI 10.1182/blood.2022017594
2. P1461: INFLAMMATORY AND SENESCENCE-ASSOCIATED MEDIATORS AFFECT THE PERSISTENCE OF HUMORAL RESPONSE TO COVID-19 MRNA VACCINATION IN TRANSFUSION-DEPENDENT BETA-THALASSEMIC PATIENTS
   Bordoni V, Casale M, Maria Pinto V, Carsetti R, et al · · 2023