Clinical trial NCT04878822: Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies
Official title: Prospective, Cohort, Non-interventional, Single-center Clinical Study of Immune Response Status to SARS-CoV-2 / Covid-19 Vaccination in Patients With Haematological Malignancies.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunogenicity
Hematological Malignancies
Covid-19
Vaccine Response Impaired
Keywords: Hematological Malignancies
Covid-19
SARS-CoV-2
Comirnaty
Moderna
Vaxzevria
Janssen
Efficacy vaccination
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with hematological malignancies who have received the anti-SARS-CoV2 / Covid-19 vaccination, with or without previous Covid-19.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* History of hematological neoplasia (myeloid neoplasms, lymphoid neoplasms, plasma cell dyscrasias).
* Active hematological neoplasm.

Exclusion Criteria:

* Hematological diseases, other than hematological malignancies.

Primary outcomes:
measure: To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination.
timeFrame: 1 month after completion of vaccination
Secondary outcomes:
measure: To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the disease and its status.
timeFrame: 1 month after completion of vaccination
measure: To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the type of vaccination.
timeFrame: 1 month after completion of vaccination
measure: To assess the antibody titer at least 28 days after the SARS-CoV-2 / Covid-19 vaccination.
timeFrame: 1 month after completion of vaccination
measure: To evaluate the persistence of the antibody titer after vaccination.
timeFrame: 28 days, 6 and 12 months after completion of vaccination
measure: To evaluate the cellular immune response to SARS-CoV-2 / Covid-19 vaccination.
timeFrame: 28 days, 6 and 12 months after completion of vaccination
measure: To evaluate the clinical efficacy of the anti SARS-CoV-2 / Covid-19 vaccination.
timeFrame: 28 days, 6 and 12 months after completion of vaccination
Other outcomes:
Locations:
city: Varese
country: Italy
facility: UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi
state: Lombardia
Study officials:
affiliation: Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy
name: Francesco Passamonti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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