Clinical trial · Observational
Analysis of Immunogenicity, Safety and Efficacy of COVID-19 Vaccines in Immunosuppressed Individuals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will evaluate the immunogenicity, safety and efficacy of vaccines against severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) in oncohematological patient population and compare the results with patients without prior oncohematological disease. The study is comprised of retrospective and prospective parts. In retrospective part, biobanked residual biological patient material and data will be used. In prospective part, vaccinated oncohematological patients and vaccinated patients without prior oncohematological disease will be invited to participate in long-term follow-up. The subjects will be invited for blood sample collection every three months from the second vaccine dose administration, i.e. 3 mos., 6 mos., 9 mos. etc. When the study subject receives booster dose, additional blood samples for immunogenicity analyses will be collected up to 14 days before and 4-8 weeks after the booster vaccine dose. The follow-up time points occurring every three months will be counted from the last vaccine's dose. Ten time points in total will be collected and tested for humoral and cellular immunogenicity. For safety analysis patient self-documented systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) occurring up to 7 days following each vaccine dose will be systematized and compared between oncohematological patients and healthy individuals. For efficacy analysis, polymerase chain reaction assay (PCR) confirmed symptomatic disease rates, hospitalization rates and mortality rates will be assessed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 Vaccines | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of proinflammatory cytokine production and immunophenotypic analysis after stimulation with overlapping S-peptides in peripheral blood mononuclear cells (PBMC) | Diagnostic Test | — | UNRESOLVED |
| Quantitative sequencing for TCR repertoires for SARS-CoV-2-specific antigens | Diagnostic Test | — | UNRESOLVED |
| S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Oncohematological patient group
- description
- Patients with prior diagnosis of oncohematological disease vaccinated with SARS-CoV-2 vaccine.
- interventionNames
- Diagnostic Test: S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests
- Diagnostic Test: Assessment of proinflammatory cytokine production and immunophenotypic analysis after stimulation with overlapping S-peptides in peripheral blood mononuclear cells (PBMC)
- Diagnostic Test: Quantitative sequencing for TCR repertoires for SARS-CoV-2-specific antigens
- label
- Healthy control group
- description
- Subjects without prior diagnosis of oncohematological disease vaccinated with SARS-CoV-2 vaccine.
- interventionNames
- Diagnostic Test: S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests
- Diagnostic Test: Assessment of proinflammatory cytokine production and immunophenotypic analysis after stimulation with overlapping S-peptides in peripheral blood mononuclear cells (PBMC)
- Diagnostic Test: Quantitative sequencing for TCR repertoires for SARS-CoV-2-specific antigens
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion criteria for oncohematological patients 1. \>/= 12 years of age. 2. Prior diagnosis of oncohematological disease. 3. The patient has signed an informed consent form. 4. The patient was vaccinated with SARS-CoV-2 vaccine. Inclusion criteria for healthy individuals 1. \>/= 12 years of age. 2. Patients without prior diagnosis of oncohematological disease. 3. The patient has signed an informed consent form. 4. The patient was vaccinated with SARS-CoV-2 vaccine. Exclusion criteria No exclusion criteria will be applied.
References
Publications (1)
- DERIVEDManeikis K, Sablauskas K, Ringeleviciute U, Vaitekenaite V, Cekauskiene R, Kryzauskaite L, Naumovas D, Banys V, Peceliunas V, Beinortas T, Griskevicius L. Immunogenicity of the BNT162b2 COVID-19 mRNA vaccine and early clinical outcomes in patients with haematological malignancies in Lithuania: a national prospective cohort study. Lancet Haematol. 2021 Aug;8(8):e583-e592. doi: 10.1016/S2352-3026(21)00169-1. Epub 2021 Jul 2. PMID 34224668