COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies (COVIDVAC OH)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Hematologic Malignancy; Solid Tumor; Vaccine Response Impaired; Cancer, Treatment-Related; Thoracic Cancer

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT04776005

APHP210640

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with malignant disease undergoing treatment at Saint Louis Hospital or Bichat Hospital (for chest cancer)
• with chemotherapy
• with chemotherapy + Immunotherapy
• with immunotherapy
• with targeted therapies
• with radiotherapy
• in the event of radiation pneumonitis after radiotherapy for lung cancers
• after pneumonectomy for lung cancer
• Patient informed and having expressed their non-opposition to participating in this research

Exclusion criteria

• Patient with a contraindication to Sars-Cov2 vaccination

Trial design

500 participants in 5 patient groups

Patients with malignant disease undergoing chemotherapy

Description:

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.

Treatment:

Other: Data collection

Patients with malignant disease undergoing chemotherapy + immunotherapy

Description:

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.

Treatment:

Other: Data collection

Patients with malignant disease undergoing immunotherapy

Description:

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.

Treatment:

Other: Data collection

Patients with malignant disease treated with targeted therapies

Description:

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.

Treatment:

Other: Data collection

Patients with malignant disease undergoing radiotherapy

Description:

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.

Treatment:

Other: Data collection