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

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ClinicalTrials.gov Identifier: NCT04776005
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

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.




Primary Outcome Measures :
  1. SARS-CoV-2 vaccine response at 12 months [ Time Frame: 12 months ]
    IgG anti-Sarc-CoV-2 S-protein titer at 12 months


Secondary Outcome Measures :
  1. Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination [ Time Frame: Day 0 ]
    Rate of patients presenting the anti Sarc-CoV-2 S-protein antibodies before vaccination in the study population.

  2. Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination [ Time Frame: Day 0 ]
    Rate of patients presenting the anti Sarc-CoV-2 N-protein antibodies before vaccination in the study population.

  3. SARS-CoV-2 vaccine response after first dose of vaccine [ Time Frame: Day 24 +/- 4 days ]
    IgG anti-Sarc-CoV-2 S-protein titer after the first injection of vaccine

  4. SARS-CoV-2 vaccine response at 3 months [ Time Frame: 3 months ]
    IgG anti-Sarc-CoV-2 S-protein titer at 3 months

  5. SARS-CoV-2 vaccine response at 6 months [ Time Frame: 6 months ]
    IgG anti-Sarc-CoV-2 S-protein titer at 6 months

  6. SARS-CoV-2 vaccine safety in the study population [ Time Frame: 12 months ]
    Occurence of the adverse events related to the SARS-CoV-2 vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776005


Contacts
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Contact: Luis TEIXEIRA, MD, PhD +33 142499613 luis.teixeira@aphp.fr

Locations
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France
Saint-Louis Hospital, AP-HP
Paris, France, 75010
Contact: Luis TEIXEIRA, MD, PhD    +33 142499613    luis.teixeira@aphp.fr   
Bichat Hospital, AP-HP
Paris, France, 75018
Contact: Gérard ZALCMAN, MD, PhD       gerard.zalcman@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Luis TEIXEIRA, MD, PhD Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04776005    
Other Study ID Numbers: 20210204
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Malignant pathology
Hematologic malignancy
COVID-19
Vaccine
Sars-CoV-2 antibody
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms, Second Primary
Neoplasms by Site
Hematologic Diseases