COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies

Solid Tumor Clinical Trial

— COVIDVAC OH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776005
• Other study ID #: APHP210640
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: February 2024

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Luis TEIXEIRA, MD, PhD
• Phone: +33 142499613
• Email: luis.teixeira[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Neoplasms, Second Primary
• Solid Tumor
• Thoracic Cancer
• Vaccine Response Impaired

Intervention

Other:
• Data collection
Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.

Locations

Country	Name	City	State
France	Bichat Hospital, AP-HP	Paris
France	Saint-Louis Hospital, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 vaccine response at 12 months	IgG anti-Sarc-CoV-2 S-protein titer at 12 months	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	SARS-CoV-2 vaccine response at 3 months	IgG anti-Sarc-CoV-2 S-protein titer at 3 months	3 months
Secondary	SARS-CoV-2 vaccine response at 6 months	IgG anti-Sarc-CoV-2 S-protein titer at 6 months	6 months
Secondary	SARS-CoV-2 vaccine safety in the study population	Occurence of the adverse events related to the SARS-CoV-2 vaccine	12 months