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

December 22, 2025 updated by: Centre Hospitalier Régional d'Orléans
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • Chu Orleans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: immunocompromised and healthy subjects

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)
Biological: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective humoral response after vaccination
Time Frame: 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.
Month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 0
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.
Month 0
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 1
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 one month after the second dose of the vaccine, compared to the proportion obtained in healthy subjects.
Month 1
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 2
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.
Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 3
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.
Month 3
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: 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.
Month 6
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 0
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)
Month 0
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 1
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)
Month 1
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 2
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)
Month 2
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: Month 3
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)
Month 3
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time Frame: 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)
Month 6
Clinical protection after vaccination
Time Frame: Month 0
Proportion of participants developing COVID-19 infection after vaccination
Month 0
Clinical protection after vaccination
Time Frame: Month 1
Proportion of participants developing COVID-19 infection after vaccination
Month 1
Clinical protection after vaccination
Time Frame: Month 2
Proportion of participants developing COVID-19 infection after vaccination
Month 2
Clinical protection after vaccination
Time Frame: Month 3
Proportion of participants developing COVID-19 infection after vaccination
Month 3
Clinical protection after vaccination
Time Frame: Month 6
Proportion of participants developing COVID-19 infection after vaccination
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Aymeric SEVE, Dr, Chu Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

February 6, 2022

Study Completion (Actual)

February 6, 2022

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2021-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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