MedTrace Logo

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

NCT04844489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2023-02-06

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2022-11-24
Completion
2022-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844489 on ClinicalTrials.gov