Clinical trial NCT05164016: Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
Official title: Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Hematopoietic System--Cancer
Transplant-Related Cancer
Solid Tumor Malignancy
Hematologic Malignancy
Solid Organ Transplant
Hematopoietic Cell Transplant
Cellular Therapy
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 21
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who meet the Eligibility Criteria.

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.

Detailed description: The investigator will collect a blood sample (about 1 teaspoon each time) from the participant when the participant receive the COVID-19 vaccine(s) as well as an additional blood samples 6 months after the last COVID-19 vaccine.

The participant will be on the study for about 6 months after the last vaccine. After the six-month blood sample is collected, the participant will be off study.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Diagnosed with a Hematological Malignancy (Group A), or
  2. Received a hematopoietic cell transplant or cellular therapy (Group B), or
  3. Diagnosed with a solid tumor malignancy (Group C).
  4. Received a solid organ transplant (Group D), or
  5. Does not have cancer and has not received any type of transplant (Group E)
* Willing and able to provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
timeFrame: 6 months after the last vaccine dose
Secondary outcomes:
measure: Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).
timeFrame: 6 months after the last vaccine dose
measure: 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).
timeFrame: 6 months after the last vaccine dose
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Le Bonheur
state: Tennessee
city: Memphis
country: United States
facility: LeBonheur
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Diego Hijano, MD
role: PRINCIPAL_INVESTIGATOR
References: