Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer

Malignant Solid Neoplasm Clinical Trial

Official title:

Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228275
• Other study ID #: ACCL21C2
• Secondary ID: NCI-2022-01919AC
• Status: Recruiting
• Start date: April 8, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Description:

PRIMARY OBJECTIVE:

I. Characterize the immunologic response following severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 vaccination in children, adolescents, and young adults with cancer who are currently receiving or who recently completed treatment with immunosuppressive therapy.

EXPLORATORY OBJECTIVES:

I. Describe the rate of post-vaccination symptomatic SARS-CoV-2 infections. II. Assess the durability of immune response to SARS-CoV-2 vaccine over 2 years.

III. Describe the longer-term impacts of vaccine immune response including subsequent COVID-19-related serious illness.

IV. To help guide future vaccine dosing and timing, at each SARS-CoV-2 vaccine dose administration determine the degree of:

IVa. Lymphopenia (absolute lymphocyte count cells/mm^3); IVb. Helper T-cell suppression (CD4 count); IVc. B-cell suppression (CD19 count). V. Provide a mechanism for data collection and banking of biospecimens for use in research regarding immune response to SARS-CoV-2 vaccination.

OUTLINE:

Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 549
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 37 Years

Eligibility

Inclusion Criteria:

• >= 6 months and =< 37 years of age at time of enrollment

• Patient plans to receive their first COVID-19 vaccine dose one of the food and drug administration (FDA) approved/FDA-emergency use authorization (EUA) approved COVID-19 vaccines OR patient already received their first COVID-19 vaccine dose =< 24 months prior to enrollment using one of the FDA approved/FDA-EUA approved COVID-19 vaccines.

• Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment

• Must have a diagnosis of cancer

• Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:

• Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer

• Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors

• Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy

• A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if it is feasible to collect required baseline study specimens within protocol mandated time period prior to the initial COVID-19 vaccine dose; or a patient who already received a COVID-19 vaccine is eligible only if feasible to collect at least one post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD follow-up specimen must be feasible as per timing requirements

• Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients enrolled prior to their first COVID-19 vaccine dose who do not receive initial vaccine dose within 3 months after enrollment will be taken off study

• All patients and/or their parents or legal guardians must sign a written informed consent

• All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

• Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after COVID-19 infection within last 90 days

• Note: patients with previous COVID-19 infection are eligible as long as requirements are met. Patients receiving intravenous immunoglobulin therapy (IVIG) therapy (i.e., post bone marrow transplantation [BMT] or chimeric antigen receptor [CAR]-T) are eligible

• Patients undergoing radiation therapy only are ineligible

• Reminder: before the planned initial COVID-19 vaccine dose, patient must be undergoing or have received cancer treatments

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	C S Mott Children's Hospital	Ann Arbor	Michigan
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Overlake Medical Center	Bellevue	Washington
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	Montefiore Medical Center-Weiler Hospital	Bronx	New York
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	University of Illinois	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	University of Florida Health Science Center - Gainesville	Gainesville	Florida
United States	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	Las Vegas Urology - Pebble	Henderson	Nevada
United States	Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Kingman Regional Medical Center	Kingman	Arizona
United States	East Tennessee Childrens Hospital	Knoxville	Tennessee
United States	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada - Town Center	Las Vegas	Nevada
United States	GenesisCare USA - Las Vegas	Las Vegas	Nevada
United States	Las Vegas Urology - Cathedral Rock	Las Vegas	Nevada
United States	Las Vegas Urology - Pecos	Las Vegas	Nevada
United States	Las Vegas Urology - Smoke Ranch	Las Vegas	Nevada
United States	Summerlin Hospital Medical Center	Las Vegas	Nevada
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Nicklaus Children's Hospital	Miami	Florida
United States	The Children's Hospital at TriStar Centennial	Nashville	Tennessee
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's Hospital and Medical Center of Omaha	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Nemours Children's Hospital	Orlando	Florida
United States	Hope Cancer Care of Nevada-Pahrump	Pahrump	Nevada
United States	Saint Joseph's Regional Medical Center	Paterson	New Jersey
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Saint Jude Midwest Affiliate	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Drexel University School of Medicine	Philadelphia	Pennsylvania
United States	Saint Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Radiation Oncology Associates	Reno	Nevada
United States	Renown Regional Medical Center	Reno	Nevada
United States	Beaumont Children's Hospital-Royal Oak	Royal Oak	Michigan
United States	Cardinal Glennon Children's Medical Center	Saint Louis	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Rady Children's Hospital - San Diego	San Diego	California
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Saint Vincent Hospital Cancer Center at Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability of immune response at 6 months	The proportion of patients with an immune response (seropositivity) at 6, 12 and 18 months after the initial dose will be calculated along with a corresponding 95% confidence interval.	At 6, 12 and 18 months after each dose
Other	Post-vaccination symptomatic SARS-CoV-2 infections	The proportion of patients with a post-vaccination symptomatic SARS-CoV-2 infection will be calculated along with a corresponding 95% confidence interval.	Up to 2 years after initial dose
Primary	Seroprevalence of SARS-CoV-2-specific protective antibodies	Will report the proportion of patients with a serologic response to a protocol-approved COVID-19 vaccine, captured using a test for SARS-CoV-2-specific antibodies via immunoassay, and will report a corresponding 95% confidence interval.	24 months following initial vaccination with a protocol-approved COVID-19 vaccine