Vaccine Response After Cancer Therapy in Pediatric Patients
Trial Summary
What is the purpose of this trial?
Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Vaccine in pediatric cancer patients?
Research shows that pediatric cancer patients can develop protective immune responses to vaccines, such as the influenza and COVID-19 vaccines, even after cancer treatment. For example, a study found that revaccinating children after cancer treatment led to protective antibody levels, and another study showed that a significant number of children responded well to the COVID-19 vaccine.12345
Is the vaccine safe for children who have undergone cancer therapy?
The safety of giving vaccines to children who have had cancer treatment is generally well-documented for inactivated vaccines (vaccines made from killed viruses or bacteria), but live vaccines (made from weakened viruses) can cause illness in these children. It's important to weigh the risks and benefits of live vaccines in this group.26789
How does the vaccine treatment differ from other treatments for pediatric cancer patients?
This vaccine treatment is unique because it focuses on assessing the immune response in pediatric cancer patients after receiving COVID-19 vaccinations, which is not commonly studied. It evaluates both antibody and T-cell responses, providing insights into how well these patients can develop immunity after cancer therapy.234510
Research Team
Ashley Hinson, MD
Principal Investigator
Wake Forest University Health Sciences
Eligibility Criteria
This trial is for pediatric cancer survivors aged 2-21 who've finished their cancer therapy within the last 60 days. They should be able to perform daily activities (with some assistance if needed) and comply with study procedures. It's not for those treated only with surgery or radiotherapy, with severe vaccine allergies, immune deficiencies, pregnancy, or active severe infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Lab evaluations for immune function at baseline
Vaccination Phase
Participants receive either single booster vaccines or a full revaccination series starting at 3 months post therapy
Follow-up
Participants are monitored for immune response and infection rates at 12 and 24 months post therapy
Treatment Details
Interventions
- Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atrium Health
Lead Sponsor
Wake Forest University Health Sciences
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator