Status:
COMPLETED
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Autoimmune or Autoinflammatory Diseases
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multicenter, non-comparative cohort study of immunocompromised people vaccinated against Covid-19 with the aim to know the humoral and cellular response to BNT162b2 vaccination against SA...
Detailed Description
The SARS-CoV-2 pandemic represents an extraordinary challenge for global health, it has caused more than 97 million cases of Covid-19 and 2 million deaths worldwide as of January 22, 2021. Vaccination...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Patients eligible for BNT162b2 vaccination
- Immunocompromised patients according to one of the following criteria:
- Patients with autoimmune or autoinflammatory diseases treated
- For at least three months
- Having received at least 0.1 mg / kg / day of prednisone (or equivalent) for at least three months
- Currently receiving at least 5 mg / day of prednisone in combination with an immunosuppressant (methotrexate, cyclosporine, mycophenolate mofetil, rapamycin, azathioprine, cyclophosphamide) or biotherapy (anti-B cells (rituximab and others) anti-TNF, IL- 1, IL-6R, IL-12/23, IL-17, or B7 (CTLA4-Ig)) or a kinase inhibitor (Janus, Tyrosine))
- HIV-infected patients with a CD4 count \<500 / mm3 and a viral load \<50 copies / ml on stable antiretroviral therapy for at least 3 months
- Patients with multiple sclerosis treated with a disease-modifying drug for at least 3 months at a stable dose (teriflunomide, dimethyl-fumarate, fingolimod, ocrelizumab, rituximab, natalizumab)
- Patients with solid tumors or cancers:
- Patients who have received active cancer treatment other than chemotherapy (targeted therapy, radiotherapy, surgery, hormone therapy) in the previous month
- Patients who have received active cancer treatment with chemotherapy (alone or in combination with immunotherapy, radiotherapy or targeted therapy) in the previous month
- Patients who have received active oncology treatment with one or more immunotherapy (s) in combination with anti-PD1, anti-PD-L1, anti-CTLA4 antibodies without chemotherapy in the previous month.
- Solid organ transplant patients for more than 3 months who have not received a depleting T agent in the induction protocol, and for\> 6 months otherwise
- Life expectancy of more than 3 months
- Having been informed about the study and having given their written and informed consent
- Beneficiaries or beneficiaries of a social security scheme
Exclusion
- Patients who may be included in more than one of the sub-cohorts
- Other vaccination received in the 15 days preceding recruitment or planned in the month following the second vaccine injection
- Known or suspected allergy to one of the components of the vaccine
- Severe reaction after previous administration of any influenza vaccine (multiple sclerosis, Guillain-Barré syndrome)
- Contact subjects of a patient with an undetected documented SARS-CoV-2 infection
- Evocative signs of COVID-19
- History of documented SARS-CoV-2 infection of less than 3 months (RT-PCR, Lamp PCR, antigen test)
- Last outbreak of the disease less than 3 months old for patients with Multiple Sclerosis; less than a month old for patients with autoimmune or autoinflammatory diseases
- For patients with HIV, transient viremia (blip) less than 3 months old
- Intercurrent infection
- For organ transplants, episode of cellular or humoral rejection during the 3 months preceding inclusion
- Healthy volunteers
- Pregnancy less than 13 weeks old according to the declaration of pregnancy
- Refusal of participation by the patient
- Patients subject to legal protection measures
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT04844489
Start Date
April 16 2021
End Date
December 31 2022
Last Update
February 6 2023
Active Locations (1)
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1
Hospital Pitié-Salpêtrière - AP-HP
Paris, France, 75013