Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults

  • STATUS
    Recruiting
  • End date
    Mar 20, 2022
  • participants needed
    240
  • sponsor
    Centre Hospitalier Régional d'Orléans
Updated on 20 July 2021
diabetes
cancer
kidney transplant
primary cancer
immunosuppression
HIV Vaccine
disease or disorder

Summary

The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.

Description

The serious, even fatal, forms of COVID-19 preferentially affect elderly and fragile subjects. Among these populations at risk, people who are immunocompromised (either by a disease and / or its treatment) have a theoretical risk of responding less well to a preventive vaccination.

The main objective of this study aims to compare the vaccine response of immunocompromised people with healthy subjects (non-immunocompromised), i.e. to assess the serum humoral response (titre and neutralizing capacity of the antibodies induced) following vaccination with ComirnatyTM (i.e. BNT162b2, an anti-SARS-CoV-2 vaccine from Pfizer BioNTech) in immunocompromised persons in comparison to healthy subjects (non-immunocompromised).

Secondary objectives are as follows:

  • To evaluate the antibody response in the nasal mucosa (titre and neutralizing capacity of the antibodies induced, collected by means of a nasopharyngeal swab) following vaccination with ComirnatyTM in immunocompromised people as compared to healthy subjects (vaccinated either with two doses of ComirnatyTM or, in a subgroup, with one dose of Astra Zeneca's VaxzeriaTM followed by one dose of ComirnatyTM).
  • Evaluate the serum and mucosal antibody response (titre and neutralizing capacity of the antibodies induced) against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains).
  • Evaluate the post-vaccination clinical protection against the risk of COVID-19 infection (incident cases after vaccination).

Details
Condition NIDDM, HIV, HIV positive, Hematologic Malignancy, HIV infection, Multiple Myeloma, Multiple Sclerosis, Blood disorder, Cancer, AIDS Vaccines, Hemodialysis, Renal transplant, Hypergammaglobulinemia, HIV Infections, Hematologic Cancer, kidney transplant, type 2 diabetes mellitus, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, multiple sclerosis (ms), human immunodeficiency virus, hiv disease, multiple myeloma (mm), HIV Vaccine, hiv vaccines, renal transplantation, kidney transplants, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Treatment biological samples
Clinical Study IdentifierNCT04952766
SponsorCentre Hospitalier Régional d'Orléans
Last Modified on20 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups
Group of immunocompromised (15 participants per immunosuppression subgroup)
Kidney transplant
Extracorporeal dialysis
Solid cancer under chemotherapy and / or radiotherapy
Myeloma under chemotherapy
Hematologic malignancies under chemotherapy
Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin
Malignant tumor under anti-PD1 or anti-PDL1
People living with HIV
Complicated type 2 diabetes (with micro and / or macroangiopathy)
Group of non-immunocompromised subjects (controls, n = 75)
people vaccinated with the ComirnatyTM
people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose

Exclusion Criteria

Minors
Pregnant or breastfeeding women
Persons under tutorship or curatorship
Protected adults
Person under legal protection
Person not affiliated to a social security scheme
People with a contraindication to receiving the ComirnatyTM vaccine
People who have already been vaccinated against SARS-CoV-2
Note: a history of COVID-19 (> at 3 months) is not a contraindication to
vaccination and is therefore not a criterion for non-inclusion in the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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