Solid TumorCOVIDVAC OHNCT04776005
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies
An observational study of Solid Tumor and Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hematologic Malignancy, Thoracic Cancer
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Jan 2021to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Patient with a contraindication to Sars-Cov2 vaccination
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Saint-Louis Hospital, AP-HP
Paris, 75010
Luis TEIXEIRA, MD, PhD, +33 142499613, luis.teixeira@aphp.fr
- Recruiting
Bichat Hospital, AP-HP
Paris, 75018
Gérard ZALCMAN, MD, PhD, gerard.zalcman@aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumor, Hematologic Malignancy, Thoracic Cancer, Cancer, Treatment-Related, Vaccine Response Impaired
- Being tested
- Data collection
- Keywords
- Malignant pathology, Hematologic malignancy, COVID-19, Vaccine, Sars-CoV-2 antibody
- Medical subject headings
- Hematologic Neoplasms, Neoplasms, Second Primary, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 vaccine response at 12 months
IgG anti-Sarc-CoV-2 S-protein titer at 12 months
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: Day 24 +/- 4 days
SARS-CoV-2 vaccine response at 3 months
IgG anti-Sarc-CoV-2 S-protein titer at 3 months
Measured: 3 months
SARS-CoV-2 vaccine response at 6 months
IgG anti-Sarc-CoV-2 S-protein titer at 6 months
Measured: 6 months
SARS-CoV-2 vaccine safety in the study population
Occurence of the adverse events related to the SARS-CoV-2 vaccine
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start22 Jan 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis TEIXEIRA, MD, PhD, Principal investigator, Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776005
- Sponsor's protocol ID
- APHP210640
- Acronym
- COVIDVAC OH
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04776005
- Acronym / sponsor ID
- COVIDVAC OH / APHP210640
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant disease undergoing chemotherapy | – | Other: Data collectionPatients 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. |
| Patients with malignant disease undergoing chemotherapy + immunotherapy | – | Other: Data collectionPatients 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. |
| Patients with malignant disease undergoing immunotherapy | – | Other: Data collectionPatients 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. |
| Patients with malignant disease treated with targeted therapies | – | Other: Data collectionPatients 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. |
| Patients with malignant disease undergoing radiotherapy | – | Other: Data collectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Patient with a contraindication to Sars-Cov2 vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionAssessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology. | Other | 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 |
Primary outcome
SARS-CoV-2 vaccine response at 12 months
Time frame: 12 months
IgG anti-Sarc-CoV-2 S-protein titer at 12 months
6 secondary outcomes
Seroprevalence of antibodies against Sarc-CoV-2 S-protein before vaccination
Time frame: Day 0
Seroprevalence of antibodies against Sarc-CoV-2 N-protein before vaccination
Time frame: Day 0
SARS-CoV-2 vaccine response after first dose of vaccine
Time frame: Day 24 +/- 4 days
SARS-CoV-2 vaccine response at 3 months
Time frame: 3 months
SARS-CoV-2 vaccine response at 6 months
Time frame: 6 months
SARS-CoV-2 vaccine safety in the study population
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis TEIXEIRA, MD, PhD principal investigator
Breast Disease Unit, Saint-Louis Hospital, APHP, Université de Paris, INSERM U976
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis TEIXEIRA, MD, PhD (+33 142499613, luis.teixeira@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 vaccine response at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.