Back to resultsStudy Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults (EREVA)
Primary Purpose
Kidney Transplant, Myeloma, Cancer
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Biological samples
Sponsored by
About this trial
This is an interventional other trial for Kidney Transplant focused on measuring SARS-CoV-2, BNT162b2 vaccine, antibody, neutralization, mucosa, immunocompromised, healthy subject
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.
Sites / Locations
- CHR d'Orleans - Service Maladies Infectieuses
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
immunocompromised and healthy subjects
Arm Description
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)
Outcomes
Primary Outcome Measures
Protective humoral response after vaccination
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
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
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.
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
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.
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
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.
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
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.
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
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.
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
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)
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
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)
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
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)
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
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)
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
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
Proportion of participants developing COVID-19 infection after vaccination
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Full Information
NCT ID
NCT04952766
First Posted
June 16, 2021
Last Updated
June 13, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT04952766
Brief Title
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
Acronym
EREVA
Official Title
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
February 6, 2022 (Actual)
Study Completion Date
February 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant, Myeloma, Cancer, Hematologic Malignancy, Multiple Sclerosis, Hypergammaglobulinemia, Malignant Tumor, Hiv, Diabetes Type 2
Keywords
SARS-CoV-2, BNT162b2 vaccine, antibody, neutralization, mucosa, immunocompromised, healthy subject
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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):
a venipuncture sample of 2 dry tubes of 7 mL (less than 30 mL in total) to make up 3 aliquots and
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)
Allocation
N/A
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immunocompromised and healthy subjects
Arm Type
Other
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Biological samples
Intervention Description
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 Measure Information:
Title
Protective humoral response after vaccination
Description
Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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.
Time Frame
Month 0
Title
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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.
Time Frame
Month 1
Title
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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.
Time Frame
Month 2
Title
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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.
Time Frame
Month 3
Title
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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.
Time Frame
Month 6
Title
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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)
Time Frame
Month 0
Title
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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)
Time Frame
Month 1
Title
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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)
Time Frame
Month 2
Title
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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)
Time Frame
Month 3
Title
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Description
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)
Time Frame
Month 6
Title
Clinical protection after vaccination
Description
Proportion of participants developing COVID-19 infection after vaccination
Time Frame
Month 0
Title
Clinical protection after vaccination
Description
Proportion of participants developing COVID-19 infection after vaccination
Time Frame
Month 1
Title
Clinical protection after vaccination
Description
Proportion of participants developing COVID-19 infection after vaccination
Time Frame
Month 2
Title
Clinical protection after vaccination
Description
Proportion of participants developing COVID-19 infection after vaccination
Time Frame
Month 3
Title
Clinical protection after vaccination
Description
Proportion of participants developing COVID-19 infection after vaccination
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aymeric SEVE, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans - Service Maladies Infectieuses
City
Orléans
ZIP/Postal Code
45067
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32817357
Citation
Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.
Results Reference
background
PubMed Identifier
33772244
Citation
Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.
Results Reference
background
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Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
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