Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19 Vaccines
  • Hematologic Neoplasms
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study will evaluate the immunogenicity, safety and efficacy of vaccines against 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, ...

The study will evaluate the immunogenicity, safety and efficacy of vaccines against 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. Ten time points in total will be collected and tested for humoral and cellular immunogenicity, detailed below. The study sample size is based on the number of oncohematological patient population, eligible for priority vaccination according to the Lithuanian Government regulations - approximately 1100 patients after stem cell transplantation and approximately 1200 oncohematological patients, who received specific treatment in the last 24 months. It is estimated, that ~20% of patients reject the vaccination, ~10% will be unreachable, ~10% reject participation in the Biobank and ~10% will be ineligible due to current treatment and disease status. Therefore, our assumed study sample is up to 1000 patients with oncohematological disease and up to 200 patients without prior oncohematological disease. The size of the control group is aimed at achieving sufficient samples for statistical comparison of the groups. All study participants will have received a vaccination schedule specified in each vaccine's Summary of Product Characteristics. For humoral immunogenicity evaluation blood serums from up to 1000 oncohematological patients and 200 healthy individuals will be tested at the following time points: 1) up to 10 days before the first vaccine dose, 2) on the day of second vaccine dose, 3) 1 to 3 weeks after second vaccine dose. Further samples will be obtained every 3 months after administration of second vaccine dose, 10 follow-up time points in total. The samples will be used to perform S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays, SARS-CoV-2 serum neutralization assay and quantitative serum immunoglobulin tests. For cellular immunogenicity evaluation PBMC samples from up to 100 oncohematological patients and 20 healthy individuals will be tested at the following time points: 1) up to 10 days before the first vaccine dose and 2) 1 to 3 weeks after second vaccine dose. Further samples will be obtained every 3 months after administration of second vaccine dose, 10 follow-up time points in total. Cellular immunogenicity will be evaluated in oncohematological patients, who may have a weak humoral response to vaccines. The following groups of oncohematological patients will be included: 1) 20 to 40 recent recipients of allogeneic stem cell transplantation (allo-SCT), meeting these requirements: 2-8 months after allo-SCT; CD3+ cell count >0.1*109/L; patients with mild chronic GvHD and/or receiving <0.5mg/kg prednisolone (or equivalent); patients with <2nd grade acute GvHD; >3 months after anti-CD20 therapy; postgraft immunosuppression with calcineurin inhibitors is allowed; 2) 20 to 40 patients after recent administration of proteasome inhibitors (0-30 days after treatment), who received at least one full cycle of treatment and achieved a satisfactory and stable disease response, allowing a safe temporary treatment discontinuation for immunization against COVID-19; 3) 20 to 40 patients after a recent anti-CD20 administration (0-180 days after treatment), who received at least one full cycle of treatment and achieved satisfactory and stable disease response, allowing a safe temporary treatment discontinuation for immunization against COVID-19. Other specific patient groups will be enrolled in the cellular immunogenicity part, as the primary analysis results show which specific subpopulations lack humoral immune response. PBMC samples from individuals without prior diagnosis of oncohematological disease will be selected randomly. The samples will be used for assessment of proinflammatory cytokine (IFN-gamma, IL-2 and IL-4) production and immunophenotypic analysis (CD45, CD3, CD4, CD8, CD16, CD56, CD14, CD19) after stimulation with overlapping S-peptides in PBMC. 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, PCR confirmed symptomatic disease rates, hospitalization rates and mortality rates will be assessed.

Tracking Information

NCT #
NCT04871165
Collaborators
Not Provided
Investigators
Not Provided