COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies

NCT04776005 | Unknown

• 1 other identifier: APHP210640
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 vaccine response at 12 months

  IgG anti-Sarc-CoV-2 S-protein titer at 12 months

  12 months

Secondary Outcomes (6)

• Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination

  Day 0

• Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination

  Day 0

• SARS-CoV-2 vaccine response after first dose of vaccine

  Day 24 +/- 4 days

• SARS-CoV-2 vaccine response at 3 months

  3 months

• SARS-CoV-2 vaccine response at 6 months

  6 months

Study Arms (5)

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

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

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

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

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

Interventions

Data collection OTHER

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 undergoing chemotherapy; Patients with malignant disease undergoing chemotherapy + immunotherapy; Patients with malignant disease undergoing immunotherapy; Patients with malignant disease undergoing radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient with a contraindication to Sars-Cov2 vaccination

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Saint-Louis Hospital, AP-HP

Paris, 75010, France

RECRUITING

Bichat Hospital, AP-HP

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms, Second Primary; COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Luis TEIXEIRA, MD, PhD

  Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis TEIXEIRA, MD, PhD

CONTACT

+33 142499613; luis.teixeira@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: January 22, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

FR (2)