64 Participants Needed

Vaccine Response After Cancer Therapy in Pediatric Patients

LF
SJ
Overseen BySceria Jenkins, RN
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Atrium Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

AH

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

Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian
My cancer was confirmed by tests and is being treated by Levine Children's Hospital.
I have had cancer before and received at least one round of treatment for it.
See 4 more

Exclusion Criteria

My cancer was treated with only surgery, radiation, or monitoring.
You have had a serious allergic reaction to a vaccine or any of its ingredients in the past.
I do not have a severe infection right now.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Lab evaluations for immune function at baseline

1 visit
1 visit (in-person)

Vaccination Phase

Participants receive either single booster vaccines or a full revaccination series starting at 3 months post therapy

3-9 months
3 visits (in-person) at 3, 6, and 9 months

Follow-up

Participants are monitored for immune response and infection rates at 12 and 24 months post therapy

24 months
2 visits (in-person) at 12 and 24 months

Treatment Details

Interventions

  • Vaccine
Trial OverviewThe study evaluates how well pediatric cancer survivors' immune systems work after treatment and how they respond to vaccinations given earlier than usual—at just 3 months post therapy. The goal is to see if this timing or revaccination can better protect against serious infections.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B - Staged revaccination seriesExperimental Treatment1 Intervention
Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.
Group II: Arm A - Single booster vaccinesExperimental Treatment1 Intervention
Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atrium Health

Lead Sponsor

Trials
122
Recruited
34,900+

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials
30
Recruited
4,700+

Findings from Research

In a study of 45 children aged 1-18 with solid tumors undergoing or recently completed chemotherapy, the influenza vaccine significantly increased antibody levels, demonstrating a strong immune response post-vaccination.
The study found that 86-97% of the children achieved protective antibody levels after receiving two doses of the vaccine, suggesting that annual vaccination is beneficial for this vulnerable population to prevent influenza-related complications.
Assessment of the immune response to trivalent split influenza vaccine in children with solid tumors.Bektas, O., Karadeniz, C., Oguz, A., et al.[2009]
A response-based re-vaccination schedule for non-transplant pediatric cancer survivors was tested, showing that most patients developed protective antibody levels after receiving vaccines 3 months post-treatment.
This approach suggests that vaccination can be effectively tailored to the individual immune recovery of pediatric cancer survivors, enhancing their protection against infections.
Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study.Han, JH., Harmoney, KM., Dokmeci, E., et al.[2018]
In a study of 46 children with cancer, those who had received chemotherapy or immunotherapy for more than 6 weeks before vaccination showed a significantly higher response to the COVID-19 vaccine, with 94.4% achieving good T-cell responses.
A third dose of the vaccine increased the antibody response in patients treated for less than 6 weeks, raising the percentage of good antibody responders from 39.3% to 70%, highlighting the importance of booster doses for this population.
Immune Response following BNT162b2 mRNA COVID-19 Vaccination in Pediatric Cancer Patients.Schmidt, KLJ., Dautzenberg, NMM., Hoogerbrugge, PM., et al.[2023]

References

Assessment of the immune response to trivalent split influenza vaccine in children with solid tumors. [2009]
Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study. [2018]
Immune Response following BNT162b2 mRNA COVID-19 Vaccination in Pediatric Cancer Patients. [2023]
[Seroconversion in response to a reinforced primary hepatitis B vaccination in children with cancer]. [2016]
Absolute lymphocyte count predicts the response to new influenza virus H1N1 vaccination in pediatric cancer patients. [2021]
Vaccinations in children with cancer. [2010]
Humoral immune response after post-chemotherapy booster diphtheria-tetanus-pertussis vaccine in pediatric oncology patients. [2008]
Active immunization of children with leukemia and other malignancies. [2019]
Loss of antibodies and response to (re-)vaccination in children after treatment for acute lymphocytic leukemia: a systematic review. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
SARS-CoV-2 vaccination response in pediatric oncology patients. [2023]