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

NCT04952766

CompletedPhase 4

Sponsor: Centre Hospitalier Régional d'Orléans

Conditions: Kidney Transplant, Myeloma, Cancer, Hematologic Malignancy, Multiple Sclerosis

Interventions: Biological samples

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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)

    * 60 people vaccinated with the ComirnatyTM
    * 15 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.

Locations (1)

Orléans, France