NCT04776005

COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies

Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used. There are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment. This multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.

Detailed description

During the visit carried out as part of the follow-up, participation in this study will be proposed to any patient who is treated for a malignant disease (solid or hematological tumors) within the university hospitals of AP-HP.Nord. The patients participating in this prospective cohort will benefit from all standard care his/her condition requires. Clinical and biological data will be collected as part of the usual follow-up. Clinical data: pathology, stage, treatment line, type of current treatment and date of the last treatment administered, previous treatments, radiotherapy, concept of radiation lung disease, history of pneumonectomy, comorbidities, performance status, history of coronavirus disease 2019 (COVID-19). Laboratory data: pre-vaccination polynuclear neutrophil count, lymphocyte counts, plasma protein electrophoresis or Ig weight dosage (routine care in hematology), lactate dehydrogenase (LDH), C-reactive protein (CRP), albuminemia in the previous month. Vaccination data: type of vaccine, date of the 1st injection, date of the 2nd injection, pre-vaccination antibody levels * Seroconversion with anti-S IgG after anti-Sars-CoV-2 vaccination * Anti-S and / or anti-N Sars-CoV-2 IgG seroprevalence before vaccination * Adverse effects related to vaccines * Levels of the anti-S IgG antibodies in AU / ml During visits between D21 and D28 (before the 2nd injection), at month 3, month 6 and month 12, the following data will be collected: * Antibody levels * Adverse effects related to vaccines * Levels of the anti-S IgG antibodies in AU / ml * Associated side effects * Occurrence of COVID-19.

Conditions

• Solid Tumor
• Hematologic Malignancy
• Thoracic Cancer
• Cancer, Treatment-Related
• Vaccine Response Impaired

Interventions

Type	Name	Description
OTHER	Data collection	Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.

Timeline

• Start date: 2021-01-22
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2021-03-01
• Last updated: 2024-01-03

Locations

2 sites across 1 country: France