Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients

NCT05164016 | Completed

• 1 other identifier: COVVIR
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being done because the investigators would like to learn more about how well the COVID-19 vaccine works in participants with cancer or those who have received a transplant or cellular therapy. Primary Objective Assess the immunogenicity to COVID-19 vaccination in patients with cancer and/or transplant and cellular therapy (TCT) recipients. Secondary Objectives

• Evaluate the antibodies response to COVID-19 vaccination in immunocompromised patients.
• Evaluate the T cell response to COVID-19 vaccination in immunocompromised patients. Exploratory Objectives
• Assess incidence and severity of COVID-19 infections by 6 months following immunization with a SARS CoV-2 vaccine.
• Assess the durability immune response to COVID-19 vaccination.
• Assess the immunogenicity of COVID-19 vaccination in immunocompetent children and adolescents without cancer and have not undergone transplant or received cellular therapy.

Conditions

Cancer; Hematopoietic System--Cancer; Transplant-Related Cancer; Solid Tumor Malignancy; Hematologic Malignancy; Solid Organ Transplant; Hematopoietic Cell Transplant; Cellular Therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with immunogenicity following full vaccination (6 months after last dose).

  The primary endpoint is immunogenicity response following full vaccination measured at 6 months after the last vaccine dose. Immunogenicity is defined as a ≥4-fold rise in the GMT of SARS-CoV-2 binding antibody to the spike protein RBD compared to the pre-vaccine baseline level or from a non-detectable GMT at the baseline to a detectable GMT after fully vaccinated. The proportion of participants with immunogenicity following full vaccination (6 months after last dose) will be described for all enrolled patients and for each disease stratum with 95% CIs. Only patients who provide a viable blood sample to evaluate immunogenicity at these time-points following completion of vaccine series will be included in this estimation.

  6 months after the last vaccine dose

Secondary Outcomes (2)

• Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).

  6 months after the last vaccine dose

• Mean and median T cell response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose and post last dose (day 180).

  6 months after the last vaccine dose

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Those who meet the Eligibility Criteria.

You may qualify if:

• Patient receiving care at St. Jude Children's Hospital or Le Bonheur Children's Hospital
• Less than 24 years old at the time of enrollment (Day 0)
• Planning to receive a COVID-19 vaccine as part of clinical care
• Patient is one of the following:
• Diagnosed with a Hematological Malignancy (Group A), or
• Received a hematopoietic cell transplant or cellular therapy (Group B), or
• Diagnosed with a solid tumor malignancy (Group C).
• Received a solid organ transplant (Group D), or
• Does not have cancer and has not received any type of transplant (Group E)
• Willing and able to provide informed consent

You may not qualify if:

• Received a COVID-19 vaccine prior to enrollment (Day 0).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (3)

Le Bonheur

Memphis, Tennessee, 38103, United States

Location

LeBonheur

Memphis, Tennessee, 38103, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St.Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Diego Hijano, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 20, 2021
• Study Start: June 29, 2022
• Primary Completion: May 1, 2025
• Study Completion: April 9, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)