Clinical trial NCT04776005: COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Hematologic Malignancy
Thoracic Cancer
Cancer, Treatment-Related
Vaccine Response Impaired
Keywords: Malignant pathology
Hematologic malignancy
COVID-19
Vaccine
Sars-CoV-2 antibody
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 vaccine response at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination
timeFrame: Day 0
measure: Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination
timeFrame: Day 0
measure: SARS-CoV-2 vaccine response after first dose of vaccine
timeFrame: Day 24 +/- 4 days
measure: SARS-CoV-2 vaccine response at 3 months
timeFrame: 3 months
measure: SARS-CoV-2 vaccine response at 6 months
timeFrame: 6 months
measure: SARS-CoV-2 vaccine safety in the study population
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital, AP-HP
city: Paris
country: France
facility: Bichat Hospital, AP-HP
Study officials:
affiliation: Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976
name: Luis TEIXEIRA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: