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

Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Thoracic Cancer; Hematologic Malignancy; Cancer, Treatment-Related; Vaccine Response Impaired
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Luis TEIXEIRA, MD, PhD; Phone Number: +33 142499613; Email: luis.teixeira@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Saint-Louis Hospital, AP-HP
    • Contact: Luis TEIXEIRA, MD, PhD; Phone Number: +33 142499613; Email: luis.teixeira@aphp.fr
  • Paris, France, 75018
    • Recruiting
    • Bichat Hospital, AP-HP
    • Contact: Gérard ZALCMAN, MD, PhD; Email: gerard.zalcman@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Luis TEIXEIRA, MD, PhD, Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Vaccine; COVID-19; Hematologic malignancy; Malignant pathology; Sars-CoV-2 antibody
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: APHP210640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No