Humoral and Cellular Immune Response to Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients with Hematologic and Solid Malignancies

• Conditions: C91.1; C90.0; C34.9; C82.9; C83.0; C83.1; C83.3; Follicular lymphoma, unspecified; Small cell B-cell lymphoma; Mantle cell lymphoma

• Registration Number: DRKS00025901
• Lead Sponsor: Medizin I, Universitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Results First Posted: 2022-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Patients must not have received any prior COVID-19 vaccination and have one of the following diagnosis (and therapy):
B-cell Non-Hodgkin’s lymphoma (Follicular lymphoma, Mantle cell lymphoma, Marginal zone lymphoma, Diffuse large B-cell lymphoma, Chronic lymphatic leukemia) without treatment (watch-and-wait”);
B-cell Non-Hodgkin’s lymphoma less than 6 months after therapy with anti-CD20 monoclonal antibodies (Rituximab, Obinutuzumab);
B-cell Non-Hodgkin’s lymphoma 6 - 60 months after therapy with anti-CD20 monoclonal antibodies;
Chronic lymphathic leukemia with Bruton´s tyrosine kinase- or BCL-2-inhibition (Venetoclax, Ibrutinib);
Multiple Myeloma (watch & wait”; treatment with Lenalidomide, Bortezomib; Daratumumab, Ixazomib, Carfilzomib);
Non Small Cell Lung Cancer (NSCLC) under PD1/PD-L1-checkpoint inhibition (Durvalumab, Pembrolizumab, Nivolumab)

Exclusion Criteria

refusal to participate;
additional immunosuppressive therapy i.e. chemotherapy;
patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons;
persons who can not give informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of anti-SARS-CoV-2-spike-specific antibodies (+ anti-NC-antibodies to assess previous COVID-19)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells;<br>immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of neutralizing antibodies against SARS-CoV-2 wildtype (D614G);<br>immunogenicity of the COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of neutralizing antibodies against different VOC PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617);<br>immunogenicity of COVID-19 vaccination 6, 12 and 18 months (+/- 2 weeks) after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies;<br>differences in humoral and cellular immunogenicity in our patients with malignant pathologies within the different hematologic malignancies and between the treatments.<br>