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Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT04878822
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Francesco Passamonti, Ospedale di Circolo - Fondazione Macchi

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.


Condition or disease
Immunogenicity Hematological Malignancies Covid-19 Vaccine Response Impaired

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
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.
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : April 30, 2023



Primary Outcome Measures :
  1. To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination. [ Time Frame: 1 month after completion of vaccination ]
    The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination.


Secondary Outcome Measures :
  1. To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the disease and its status. [ Time Frame: 1 month after completion of 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.

  2. To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the type of vaccination. [ Time Frame: 1 month after completion of vaccination ]
    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).

  3. To assess the antibody titer at least 28 days after the SARS-CoV-2 / Covid-19 vaccination. [ Time Frame: 1 month after completion of vaccination ]
    The distribution and median of the antibody titer at least 28 days after vaccination.

  4. To evaluate the persistence of the antibody titer after vaccination. [ Time Frame: 28 days, 6 and 12 months after completion of vaccination ]
    The difference between the antibody titer at 28 days and at 6 and 12 months after vaccination.

  5. To evaluate the cellular immune response to SARS-CoV-2 / Covid-19 vaccination. [ Time Frame: 28 days, 6 and 12 months after completion of 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.

  6. To evaluate the clinical efficacy of the anti SARS-CoV-2 / Covid-19 vaccination. [ Time Frame: 28 days, 6 and 12 months after completion of 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.


Biospecimen Retention:   Samples Without DNA
Peripheral blood samples


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
Subjects with hematological malignancies who have received the anti-SARS-CoV2 / Covid-19 vaccination, with or without previous Covid-19.
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.

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): NCT04878822


Contacts
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Contact: Francesco Passamonti, MD +39-0332-393648 francesco.passamonti@asst-settelaghi.it
Contact: Marco Salvini, MD marcosalvini83@gmail.com

Locations
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Italy
UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi Recruiting
Varese, Lombardia, Italy, 21100
Contact: Francescp Passamonti, MD    +39-0332-393648    francesco.passamonti@asst-settelaghi.it   
Contact: Marco Salvini, MD       marcosalvini83@gmail.com   
Sponsors and Collaborators
Ospedale di Circolo - Fondazione Macchi
Investigators
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Principal Investigator: Francesco Passamonti, MD Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy
Additional Information:
Publications:
Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, Angelucci E, Krampera M, Cairoli R, Della Porta MG, Fracchiolla N, Ladetto M, Gambacorti Passerini C, Salvini M, Marchetti M, Lemoli R, Molteni A, Busca A, Cuneo A, Romano A, Giuliani N, Galimberti S, Corso A, Morotti A, Falini B, Billio A, Gherlinzoni F, Visani G, Tisi MC, Tafuri A, Tosi P, Lanza F, Massaia M, Turrini M, Ferrara F, Gurrieri C, Vallisa D, Martelli M, Derenzini E, Guarini A, Conconi A, Cuccaro A, Cudillo L, Russo D, Ciambelli F, Scattolin AM, Luppi M, Selleri C, Ortu La Barbera E, Ferrandina C, Di Renzo N, Olivieri A, Bocchia M, Gentile M, Marchesi F, Musto P, Federici AB, Candoni A, Venditti A, Fava C, Pinto A, Galieni P, Rigacci L, Armiento D, Pane F, Oberti M, Zappasodi P, Visco C, Franchi M, Grossi PA, Bertù L, Corrao G, Pagano L, Corradini P; ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol. 2020 Oct;7(10):e737-e745. doi: 10.1016/S2352-3026(20)30251-9. Epub 2020 Aug 13.
García-Suárez J, de la Cruz J, Cedillo Á, Llamas P, Duarte R, Jiménez-Yuste V, Hernández-Rivas JÁ, Gil-Manso R, Kwon M, Sánchez-Godoy P, Martínez-Barranco P, Colás-Lahuerta B, Herrera P, Benito-Parra L, Alegre A, Velasco A, Matilla A, Aláez-Usón MC, Martos-Martínez R, Martínez-Chamorro C, Susana-Quiroz K, Del Campo JF, de la Fuente A, Herráez R, Pascual A, Gómez E, Pérez-Oteyza J, Ruiz E, Alonso A, González-Medina J, Martín-Buitrago LN, Canales M, González-Gascón I, Vicente-Ayuso MC, Valenciano S, Roa MG, Monteliu PE, López-Jiménez J, Escobar CE, Ortiz-Martín J, Diez-Martin JL, Martinez-Lopez J; Asociación Madrileña de Hematología y Hemoterapia (AMHH). Impact of hematologic malignancy and type of cancer therapy on COVID-19 severity and mortality: lessons from a large population-based registry study. J Hematol Oncol. 2020 Oct 8;13(1):133. doi: 10.1186/s13045-020-00970-7.
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.

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Responsible Party: Francesco Passamonti, Principal Investigator, Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier: NCT04878822    
Other Study ID Numbers: ImmunoHaema-COVID-VAX-21
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francesco Passamonti, Ospedale di Circolo - Fondazione Macchi:
Hematological Malignancies
Covid-19
SARS-CoV-2
Comirnaty
Moderna
Vaxzevria
Janssen
Efficacy vaccination
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases