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NCT Number: NCT04666025

SARS-CoV-2 Donor-Recipient Immunity Transfer

This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.

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Key information

Conditions

Accelerated Phase CML, BCR-ABL1 Positive Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Bone Marrow Diseases COVID-19 COVID-19 Infection Chronic Disease Chronic Lymphocytic Leukemia Chronic Phase CML, BCR-ABL1 Positive Coronaviridae Infections Coronavirus Infections Disease Attributes Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Lung Diseases Lymphatic Diseases Lymphoblastic Lymphoma Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Myelofibrosis Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nidovirales Infections Non-Hodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

PRIMARY OBJECTIVE:

I. To establish the possibility of anti-SARS-CoV-2 adaptive immunity transfer from matched related (MRD) or unrelated (MUD) HCT donor to HCT recipient.

SECONDARY OBJECTIVES:

I. To explore anti-SARS-CoV-2 adaptive immunity transfer in the haploidentical (haplo) HCT setting.

II. To assess the prevalence and change over time of SARS-CoV-2 seropositive donors among all consented donors.

OUTLINE:

DONORS: Prior to HCT, sibling donors (MRD and haplo) undergo a nasopharyngeal swab per standard of care for SARS-Cov-2 testing. For MUD donors, initial testing may consist of a questionnaire. All donors undergo collection of blood and saliva at the time of granulocyte-colony stimulating factor (G-CSF). Donors' medical charts are also reviewed.

RECIPIENTS: Patients undergo a nasopharyngeal swab for SARS-Cov-2 testing at 30, 60, 90, 120 days post-HCT, and afterwards as deemed necessary by the treating physician. Patients also undergo the collection of blood and saliva specimens at days 30, 60, 90, 120, 150, and 180 post-HCT. Recipients' medical charts are also reviewed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ALL COHORTS: Documented written informed consent of the participant
  • ALL COHORTS: Recipients must have a planned allogeneic HCT procedure. MRD, MUD, and haplo HCT allowed. Usage of post-transplant cyclophosphamide (PTCy) permitted only in haplo setting
  • ALL COHORTS: GCSF-mobilized peripheral blood stem cell (PBSC) only as graft source
  • ALL COHORTS: Planned HCT with minimal to no-T cell depletion of graft for the treatment of the following hematologic malignancies:
  • Lymphoma (Hodgkin and non-Hodgkin)
  • Myelodysplastic syndrome
  • Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)
  • Acute myeloid leukemia in first or second remission
  • Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
  • Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis
  • ALL COHORTS: Willingness to
  • Provide blood samples and saliva specimens
  • Permit medical record review
  • ADDITIONAL CRITERIA FOR RECIPIENTS IN THE MAIN COHORT:
  • Absence of documented COVID-19 history and active COVID-19 infection
  • ADDITIONAL CRITERIA FOR RECIPIENTS IN THE REFERENCE COHORT: Active COVID-19 infection during HCT

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of nasopharyngeal swabs, blood, and saliva samples

diagnostic laboratory biomarker analysis

Other

Correlative studies

Electronic Health Record Review

Other

Medical charts are reviewed

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels

    Time frame: Up to 180 days post-hematopoietic stem cell transplant (HCT)

    Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.

  2. SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels

    Time frame: Up to 180 days post-HCT

    Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

  3. SARS-CoV-2 neutralizing antibodies

    Time frame: Up to 180 days post-HCT

    Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.

Secondary outcomes

  1. SARS-CoV-2 IgA concentration

    Time frame: Up to 180 days post-HCT

    Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA.

Other outcomes

  1. SARS-CoV-2 -specific T cell memory profile and associated function

    Time frame: Up to 180 days post-HCT

    The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S or SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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