Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Y… (NCT05228275) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
United States549 participantsStarted 2022-04-08
Plain-language 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.
Who can participate
Age range
6 Months – 37 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroprevalence of SARS-CoV-2-specific protective antibodies
Timeframe: 24 months following initial vaccination with a protocol-approved COVID-19 vaccine