Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
During visits between D21 and D28 (before the 2nd injection), at month 3, month 6 and month 12, the following data will be collected:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with malignant disease undergoing chemotherapy | Patients with malignant disease undergoing chemotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus. |
| |
| Patients with malignant disease undergoing chemotherapy + immunotherapy | Patients with malignant disease undergoing chemotherapy + immunotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus. |
| |
| Patients with malignant disease undergoing immunotherapy | Patients with malignant disease undergoing immunotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus. |
| |
| Patients with malignant disease treated with targeted therapies | Patients with malignant disease treated with targeted therapies within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus. |
| |
| Patients with malignant disease undergoing radiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 vaccine response at 12 months | IgG anti-Sarc-CoV-2 S-protein titer at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination | Rate of patients presenting the anti Sarc-CoV-2 S-protein antibodies before vaccination in the study population. | Day 0 |
| Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are treated for a malignant disease (solid or hematological tumors) within the CHU AP-HP.Nord and who are willing to get a SARS-CoV-2 vaccination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis TEIXEIRA, MD, PhD | Contact | +33 142499613 | luis.teixeira@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Luis TEIXEIRA, MD, PhD | Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Louis Hospital, AP-HP | Recruiting | Paris | 75010 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D016609 | Neoplasms, Second Primary |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with malignant disease undergoing radiotherapy within the University Hospital Centre AP-HP.Nord, who have voluntarily agreed to be vaccinated with an approved vaccine against the Sars-CoV-2 virus.
|
Rate of patients presenting the anti Sarc-CoV-2 N-protein antibodies before vaccination in the study population. |
| Day 0 |
| SARS-CoV-2 vaccine response after first dose of vaccine | IgG anti-Sarc-CoV-2 S-protein titer after the first injection of vaccine | Day 24 +/- 4 days |
| SARS-CoV-2 vaccine response at 3 months | IgG anti-Sarc-CoV-2 S-protein titer at 3 months | 3 months |
| SARS-CoV-2 vaccine response at 6 months | IgG anti-Sarc-CoV-2 S-protein titer at 6 months | 6 months |
| SARS-CoV-2 vaccine safety in the study population | Occurence of the adverse events related to the SARS-CoV-2 vaccine | 12 months |
| Bichat Hospital, AP-HP | Recruiting | Paris | 75018 | France |
|
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |