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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03111589
Date of registration:	07/04/2017
Prospective Registration:	No
Primary sponsor:	Francis Corazza
Public title:	Monocytic Expression of Heme Oxidase-1 (HO-1) in Sickle Cell Patients and Correlation With the Humoral Immune Response to Vaccine and With Allo-immunization.
Scientific title:	Monocytic Expression of Heme Oxidase-1 (HO-1) in Sickle Cell Patients and Correlation With the Humoral Immune Response to Vaccine and With Allo-immunization
Date of first enrolment:	October 2016
Target sample size:	102
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03111589
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Francis Corazza, MD
Address:
Telephone:
Email:
Affiliation:	CHU Brugmann

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pediatric and adult patients with sickle cell disease from the HUDERF and CHU-Brugmann
Hospital

Exclusion Criteria:

- None

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sickle Cell Disease

Intervention(s)

Biological: Inactivated influenza A (H1N1) virus vaccine

Diagnostic Test: Blood sampling

Primary Outcome(s)

Identification of T regulatory cells [Time Frame: 1 month post vaccination]

Intracellular HO-1 expression in monocytes [Time Frame: 1 month post vaccination]

Cytokines levels measurement [Time Frame: 1 month post vaccination]

Immune response to vaccination [Time Frame: 1 month post vaccination]

HO-1 level in serum [Time Frame: 1 month post vaccination]

Secondary Outcome(s)

Identification of T regulatory cells [Time Frame: 6 months post vaccination]

Cytokines levels measurement [Time Frame: Baseline: at vaccination]

HO-1 level in serum [Time Frame: 6 months post vaccination]

HO-1 level in serum [Time Frame: Baseline: at vaccination]

Intracellular HO-1 expression in monocytes [Time Frame: Baseline: at vaccination]

Cytokines levels measurement [Time Frame: 6 months post vaccination]

Immune response to vaccination [Time Frame: 3 months post vaccination]

HO-1 level in serum [Time Frame: 3 months post vaccination]

Identification of T regulatory cells [Time Frame: 3 months post vaccination]

Immune response to vaccination [Time Frame: Baseline: at vaccination]

Intracellular HO-1 expression in monocytes [Time Frame: 3 months post vaccination]

Cytokines levels measurement [Time Frame: 3 months post vaccination]

Immune response to vaccination [Time Frame: 6 months post vaccination]

Identification of T regulatory cells [Time Frame: Baseline: at vaccination]

Intracellular HO-1 expression in monocytes [Time Frame: 6 months post vaccination]

Secondary ID(s)

CHUB-HO1 sickle cell

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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