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Analysis of Immunogenicity, Safety and Efficacy of COVID-19 Vaccines in Immunosuppressed Individuals

NCT04871165 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3270

Last updated 2022-01-14

No results posted yet for this study

Summary

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

  • Hematologic Neoplasms
  • COVID-19 Vaccines

Interventions

DIAGNOSTIC_TEST

S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests

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)

Quantitative evaluation of proinflammatory cytokine (IFN-gamma, IL-2 and IL-4) production after stimulation with overlapping S-peptides in peripheral blood mononuclear cells and immunophenotypic analysis (CD45, CD3, CD4, CD8, CD16, CD56, CD14, CD19)

DIAGNOSTIC_TEST

Quantitative sequencing for TCR repertoires for SARS-CoV-2-specific antigens

Quantitative sequencing for TCR repertoires for SARS-CoV-2-specific antigens

Sponsors & Collaborators

  • Vilnius University

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871165 on ClinicalTrials.gov