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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04776005

Collaborator

(none)

500

Enrollment

Locations

23.3

Anticipated Duration (Months)

250

Patients Per Site

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Hematologic Malignancy Thoracic Cancer Cancer, Treatment-Related Vaccine Response Impaired	Other: Data collection

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 22, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Data collection Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
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.	Other: Data collection Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
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.	Other: Data collection Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
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.	Other: Data collection Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
Patients with malignant disease undergoing radiotherapy 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.	Other: Data collection Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 vaccine response at 12 months [12 months]
IgG anti-Sarc-CoV-2 S-protein titer at 12 months

Secondary Outcome Measures

Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination [Day 0]
Rate of patients presenting the anti Sarc-CoV-2 S-protein antibodies before vaccination in the study population.
Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination [Day 0]
Rate of patients presenting the anti Sarc-CoV-2 N-protein antibodies before vaccination in the study population.
SARS-CoV-2 vaccine response after first dose of vaccine [Day 24 +/- 4 days]
IgG anti-Sarc-CoV-2 S-protein titer after the first injection of vaccine
SARS-CoV-2 vaccine response at 3 months [3 months]
IgG anti-Sarc-CoV-2 S-protein titer at 3 months
SARS-CoV-2 vaccine response at 6 months [6 months]
IgG anti-Sarc-CoV-2 S-protein titer at 6 months
SARS-CoV-2 vaccine safety in the study population [12 months]
Occurence of the adverse events related to the SARS-CoV-2 vaccine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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