Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People

NCT04844489 | Completed

• 2 other identifiers: APHP2103052021-A00469-32
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Autoimmune or Autoinflammatory Diseases; HIV; Multiple Sclerosis; Solid Tumors or Cancers; Solid Organ Transplant

Keywords

Covid-19; Vaccination; Variants; Neutralizing antibodies; Cellular immunity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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

Study Arms (1)

Blood samples

OTHER

Other: Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19

Interventions

Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19 OTHER

Blood samples at: * D0 (the day of the injection of the SARS-CoV-2 vaccine), * during the 2nd injection as part of the national vaccination campaign (on D28) * during the 3rd injection for patients for whom a third injection is recommended (according to the recommendations in force) * then to M1, M6 and M12 of the last injection

Blood samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Location

Related Publications (1)

• Louapre C, Belin L, Marot S, Hippolyte A, Januel E, Ibrahim M, Jeantin L, Zafilaza K, Malet I, Charbonnier-Beaupel F, Rosenzwajg M, Soulie C, Marcelin AG, Pourcher V. Three to four mRNA COVID-19 vaccines in multiple sclerosis patients on immunosuppressive drugs: Seroconversion and variant neutralization. Eur J Neurol. 2023 Sep;30(9):2781-2792. doi: 10.1111/ene.15925. Epub 2023 Jun 25.

  PMID: 37310391 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Neoplasms; COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 14, 2021
• Study Start: April 16, 2021
• Primary Completion: November 24, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2021-06

Locations

FR (1)