Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

COVID-19

Hematologic Neoplasms

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Hematologic Diseases

Francesco Passamonti, MD

Covid-19 is associated with a mortality rate of 33-37% in patients with hematological malignancies.

At present, the anti-SARS-CoV-2 vaccination represents the most effective strategy for the prevention of Covid-19. Patients with malignancies were excluded from the trials leading to the approval of Comirnaty, Moderna, Vaxzevria and Janssen vaccines. The immunogenicity of these vaccines in immunocompromised patients or with hematological malignancies is an unmet clinical need.

The aim of the study is to evaluate the efficacy of vaccination in adult patients with hematological malignancies, who received vaccination according to Italian rules and were in treatment at the Hematology Unit of Varese, Italy Efficacy will be evaluated in terms of serological response, cellular-mediated immune response and prevention of Covid-19.

The duration of the study will be 24 months.

Covid-19 is associated with a mortality rate of 33-37% in patients with hematological malignancies (Passamonti et al, 2020; Garcia-Suarez et al, 2020). Currently, there is little information on the serological response following SARS-Cov-2 infection in this specific population.

At present, the anti-SARS-CoV-2 vaccination represents the most effective strategy for the prevention of Covid-19. The anti-SARS-CoV-2 vaccines currently approved by the European Medicines Agency (EMA) and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) are: the BNT162b2 SARS-Cov-2 (Pfizer-BioNTech, Comirnaty) vaccine, the mRNA-1273 SARS-Cov-2 (Moderna) vaccine, the ChAdOx1 nCoV-19 (Vaxzevria) vaccine, and the Ad26.COV2.S (Janssen) vaccine.

The double-dose regimen of Pfizer-BioNTech vaccine showed 95% efficacy at preventing Covid-19 (Polack et al, 2020), the double-dose regimen of Moderna vaccine showed 94.1% efficacy (Baden et al, 2021), the double-dose regimen of Vaxzevria vaccine showed 70.4% efficacy (Voysey et al, 2021), while the single-dose regimen of Janssen vaccine was found to be 66.1% effective (Sadoff et al, 2021).

The Italian national Covid-19 vaccination plan included patients with active malignancies in the second priority group, recognizing the importance of protecting this vulnerable population from SARS-Cov-2 infection. Since vaccine clinical trials excluded patients with malignancies and patients undergoing immunosuppressive therapies, the immunological response to anti-SARS-CoV-2 vaccines in these patients is currently unknown.

In this prospective, cohort, non-interventional study, our objective is to evaluate both the humoral and the cellular immune response to anti-SARS-CoV-2 vaccination in adults with hematological malignancies. For each patient the immune response will be evaluated after a minimum of 28 days from the completion of the vaccination regimen. Then, it will be reassessed after 6 and 12 months. In our center, the humoral immune response will be assessed by using the DiaSorin's LIAISON SARS-CoV-2 S1/S2 IgG test, which quantifies the level of anti-SARS-CoV-2 IgG antibodies that are active against the S1 and S2 subunits of the S protein. The cell-mediated immune response will be assessed on peripheral blood cells through a phenotypic and functional analysis by flow cytometry and through the ELISPOT test. Each patients will sign an informed consensus for the participation. The total duration of the study will be 24 months.

Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies

Prospective, Cohort, Non-interventional, Single-center Clinical Study of Immune Response Status to SARS-CoV-2 / Covid-19 Vaccination in Patients With Haematological Malignancies.

The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination.

The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination in myeloid, lymphoid and plasma cell dyscrasias sub-categorized by status of disease, status and type of treatment.

The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination described by vaccine brand (currently Comirnaty, Moderna, Vaxzevria, Janssen).

The distribution and median of the antibody titer at least 28 days after vaccination.

The difference between the antibody titer at 28 days and at 6 and 12 months after vaccination.

The percentage of patients who generated immune cells with IFN-gamma cytokine response after at least 28 days, 6 and 12 months after vaccination.

The percentage of patients with any among: 1) positive molecular swab by RT-PCR, 2) documented symptomatic Covid-19 disease; 3) hospitalization for Covid-19; 4) documented severe Covid-19 disease; 5) death from Covid-19 despite vaccination.

Ospedale di Circolo - Fondazione Macchi

Principal Investigator

Neoplasms, Second Primary

All Drugs and Chemicals

Antibodies

Vaccines

Immunomodulating Agents

Immunoglobulins

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.

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.

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.

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.

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.

Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.

Data collection

Luis TEIXEIRA, MD, PhD

Gérard ZALCMAN, MD, PhD

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.

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.

COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies

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

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

Rate of patients presenting the anti Sarc-CoV-2 S-protein antibodies before vaccination in the study population.

Rate of patients presenting the anti Sarc-CoV-2 N-protein antibodies before vaccination in the study population.

IgG anti-Sarc-CoV-2 S-protein titer after the first injection of vaccine

IgG anti-Sarc-CoV-2 S-protein titer at 3 months

IgG anti-Sarc-CoV-2 S-protein titer at 6 months

Occurence of the adverse events related to the SARS-CoV-2 vaccine

Assistance Publique - Hôpitaux de Paris

Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.

Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

SARS-COV2 Pfizer Vaccine

Rachna Shroff, MD

Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

Immune Response to the COVID-19 Vaccine

Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.

Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by T-cell quantification in blood samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies	NCT04878822	Immunogenicity Hematological M... Covid-19 Vaccine Respons...		18 Years -	Ospedale di Circolo - Fondazione Macchi
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies	NCT04776005	Solid Tumor Hematologic Mal... Thoracic Cancer Cancer, Treatme... Vaccine Respons...	Data collection	18 Years -	Assistance Publique - Hôpitaux de Paris
Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies	NCT04878822	Immunogenicity Hematological M... Covid-19 Vaccine Respons...		18 Years -	Ospedale di Circolo - Fondazione Macchi
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies	NCT04776005	Solid Tumor Hematologic Mal... Thoracic Cancer Cancer, Treatme... Vaccine Respons...	Data collection	18 Years -	Assistance Publique - Hôpitaux de Paris
Immune Response to the COVID-19 Vaccine	NCT04936997	Covid19 Cancer Malignancy Vaccine Respons...	SARS-COV2 Pfize...	18 Years -	University of Arizona

Spots Global Cancer Trial Database for vaccine response impaired