Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776005
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-02-26
Brief Title:
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multicenter Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP Nord
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDVAC OH
Brief 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
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-HPNord
The patients participating in this prospective cohort will benefit from all standard care hisher 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
The patients participating in this prospective cohort will benefit from all standard care hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None