Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellul
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19
What it measured
Main measures
Proportion of patients with a neutralizing antibody titer greater than 1/10 towards the wild strain and the English VOC 202012/01, South African 501Y.V2 variants and any other variants that may emerge
At the third injection visit and at one, six and twelve months after the last injection
Immune response
Other measures (9)
Proportion of patients with a positive serology by detection of IgG anti-receptor-binding domain (RBD) antibodies to the Spike protein of SARS-CoV-2 measured by the SARS-CoV technique -2 IgG II Quant assay (Abbott)
At second and third injection visits and at one, six and twelve months after the last injection
Proportion of patients with a positive serology by detection of the anti-Spike protein IgG antibodies of SARS-CoV-2 measured by the Euroimmun technique
At second and third injection visits and at one, six and twelve months after the last injection
Proportion of patients with positive anti-RBD IgG serology on D0
At inclusion visit
Anti-RBD IgG level
At second and third injection visits and at one, six and twelve months after the last injection
Antibody neutralization title
At second and third injection visits and at one, six and twelve months after the last injection
Neutralization title for antibodies against the wild strain and to the English VOC 202012/01, South African 501Y.V2 variants and any other variants that could be introduced to emerge.
At second and third injection visits and at one, six and twelve months after the last injection
Supervised and unsupervised analyzes of deep immunophenotyping of T and B lymphocytes
At Day 0, at the third injection visit and at one month after the last injection
Immune responseCytometric measurement of intracellular cytokines (IFN, TNF, IL-2, IL4, IL10, IL-17) after stimulation of T lymphocytes by pools of SARS-CoV-2, CMV, EBV and influenza peptides
At Day 0, at the third injection visit and at one month after the last injection
Immune responseStructure and specificity of the TCR (T-cells Receptors) repertoire of blood cells
At Day 0, at the third injection visit and at one month after the last injection
Immune response
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Age greater than or equal to 18 years * Patients eligible for BNT162b2 vaccination * Immunocompromised patients according to one of the following criteria: 1. Patients with autoimmune or autoinflammatory diseases treated 1. For at least three months 2. Having received at least 0.1 mg / kg / day of prednisone (or equivalent) for at least three months 3. 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)) 2. 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 3. 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) 4. Patients with solid tumors or cancers: 1. Patients who have received active cancer treatment other than chemotherapy (targeted therapy, radiotherapy, surgery, hormone therapy) in the previous month 2. Patients who have received active cancer treatment with chemotherapy (alone or in combination with immunotherapy, radiotherapy or targeted therapy) in the previous month 3. 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. 5. 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 criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 SARS-CoV-2 variants. This study will enroll patients in 5 parallel sub-cohorts of the same size, distinct according to the source of the immunosuppression: autoimmune or auto-inflammatory disease, HIV infection, multiple sclerosis, solid cancer, organ transplantation with prospective data collection and constitution of biological collections.
Papers
Loading reviews and guidelines…
History
Started
Apr 2021
Main results due
Nov 2022
Finished
Dec 2022