Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871165
Status:
UNKNOWN
Last Update Posted:
2022-01-14
First Post:
2021-04-20
Brief Title:
Analysis of Immunogenicity Safety and Efficacy of COVID-19 Vaccines in Immunosuppressed Individuals
Sponsor:
Vilnius University
Organization:
Vilnius University
Study Overview
Official Title:
Analysis of Immunogenicity Safety and Efficacy of COVID-19 Vaccines in Immunosuppressed Individuals
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 vaccines 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
Detailed 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 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 ie 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 vaccines dose 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 vaccination Our assumed study sample size during the whole study period is up to 2500 adult patients up to 200 adolescent patients with oncohematological disease and up to 500 adult up to 70 adolescent 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 vaccines Summary of Product Characteristics
For humoral immunogenicity evaluation blood serums from up to 2500 adult patients up to 200 adolescent patients with oncohematological disease and up to 500 adult up to 70 adolescent patients without prior oncohematological disease 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 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 vaccines dose 10 follow-up time points in total The samples will be used to perform S-binding immunoglobulin G IgG receptor-binding domain RBD-binding IgG and N-binding IgG immunoassays SARS-CoV-2 serum neutralization assay against different SARS-CoV-2 variants 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 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 vaccines dose Ten 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 cluster of differentiation 3 CD3 positive cell count 01109L patients with mild chronic graft-versus-host disease GvHD andor receiving 05mgkg 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 interferon-gamma IFN-gamma interleukin-2 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
Cellular immunogenicity will be evaluated by performing quantitative sequencing for T-cell receptor TCR repertoires for SARS-CoV-2-specific antigens using immunoSEQ technology Adaptive Biotechnologies Inc 1165 Eastlake Ave E Seattle Washington 98109 United States
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 In case of detected breakthrough infection additional biological samples will be obtained as soon as possible to evaluate humoral and cellular immunity at the time of infection and repeated until PCR-negativity is achieved
The study sample size is based on the number of oncohematological patient population eligible for vaccination Our assumed study sample size during the whole study period is up to 2500 adult patients up to 200 adolescent patients with oncohematological disease and up to 500 adult up to 70 adolescent 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 vaccines Summary of Product Characteristics
For humoral immunogenicity evaluation blood serums from up to 2500 adult patients up to 200 adolescent patients with oncohematological disease and up to 500 adult up to 70 adolescent patients without prior oncohematological disease 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 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 vaccines dose 10 follow-up time points in total The samples will be used to perform S-binding immunoglobulin G IgG receptor-binding domain RBD-binding IgG and N-binding IgG immunoassays SARS-CoV-2 serum neutralization assay against different SARS-CoV-2 variants 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 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 vaccines dose Ten 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 cluster of differentiation 3 CD3 positive cell count 01109L patients with mild chronic graft-versus-host disease GvHD andor receiving 05mgkg 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 interferon-gamma IFN-gamma interleukin-2 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
Cellular immunogenicity will be evaluated by performing quantitative sequencing for T-cell receptor TCR repertoires for SARS-CoV-2-specific antigens using immunoSEQ technology Adaptive Biotechnologies Inc 1165 Eastlake Ave E Seattle Washington 98109 United States
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 In case of detected breakthrough infection additional biological samples will be obtained as soon as possible to evaluate humoral and cellular immunity at the time of infection and repeated until PCR-negativity is achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None