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

Phase 4

Completed

• Conditions: Kidney Transplant; Multiple Sclerosis; Hypergammaglobulinemia; Hiv; Diabetes Type 2; Myeloma; Hematologic Malignancy; Cancer; Malignant Tumor
• Interventions: Biological: Biological samples

• Registration Number: NCT04952766
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2021-03-26
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-07
• Primary Completion: 2022-02-06
• Study Completion: 2022-02-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immunocompromised and healthy subjects	Biological samples	Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)

Primary Outcome Measures

Name	Time	Method
Protective humoral response after vaccination	Month 2	Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.

Secondary Outcome Measures

Name	Time	Method
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)	Month 6	Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Clinical protection after vaccination	Month 6	Proportion of participants developing COVID-19 infection after vaccination
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)	Month 6	Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.

Trial Locations

Locations (1)

CHR d'Orleans - Service Maladies Infectieuses; 🇫🇷 Orléans, France