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

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ClinicalTrials.gov Identifier: NCT04952766
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Myeloma Cancer Hematologic Malignancy Multiple Sclerosis Hypergammaglobulinemia Malignant Tumor Hiv Diabetes Type 2 Biological: Biological samples Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

All participants wil have at each of the 4 visits (for patients starting at month 1) or 5 visits (for patients starting at month 0):

  1. a venipuncture sample of 2 dry tubes of 7 mL (less than 30 mL in total) to make up 3 aliquots and
  2. a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. Clinical protection after vaccination [ Time Frame: Month 0 ]
    Proportion of participants developing COVID-19 infection after vaccination

  12. Clinical protection after vaccination [ Time Frame: Month 1 ]
    Proportion of participants developing COVID-19 infection after vaccination

  13. Clinical protection after vaccination [ Time Frame: Month 2 ]
    Proportion of participants developing COVID-19 infection after vaccination

  14. Clinical protection after vaccination [ Time Frame: Month 3 ]
    Proportion of participants developing COVID-19 infection after vaccination

  15. Clinical protection after vaccination [ Time Frame: Month 6 ]
    Proportion of participants developing COVID-19 infection after vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952766


Contacts
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Contact: Laurent HOCQUELOUX, Dr +33238229588 laurent.hocqueloux@chr-orleans.fr

Locations
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France
CHR d'Orleans - Service Maladies Infectieuses Recruiting
Orléans, France, 45067
Contact: Aymeric SEVE, Dr       aymeric.seve@chr-orleans.fr   
Principal Investigator: Aymeric SEVE, Dr         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Aymeric SEVE, Dr CHR d'Orléans
Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04952766    
Other Study ID Numbers: CHRO-2021-04
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
SARS-CoV-2
BNT162b2 vaccine
antibody
neutralization
mucosa
immunocompromised
healthy subject
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Multiple Sclerosis
Hypergammaglobulinemia
Diabetes Mellitus, Type 2
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Blood Protein Disorders
Immunoproliferative Disorders