Immunization Response for Childhood Cancer Survivors

No longer recruiting at 1 trial location
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of new vaccinations for children who have survived cancer. Cancer treatment can alter the body's vaccine response, so the study aims to determine the best way to protect these children from diseases like measles, mumps, and whooping cough. The trial uses different vaccination schedules based on age groups. It suits children diagnosed with cancer before age 18 who completed chemotherapy within the past 3 to 24 months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs, you cannot participate in the trial.

Is there any evidence suggesting that this immunization schedule is likely to be safe for childhood cancer survivors?

Research has shown that vaccines are generally safe and effective for children, including those who have had cancer. Most pediatric cancer doctors recommend restarting vaccinations about 6 months to a year after chemotherapy, allowing the immune system time to recover from cancer treatment.

One study found that many children who have survived cancer can catch up on their vaccinations without major problems. Today's vaccines are designed to be safe and work by targeting substances that trigger an immune response. While vaccines are usually well-tolerated, they can cause mild side effects like soreness at the injection site or a slight fever. These effects are generally minor and temporary.

Overall, strong evidence supports the safety of vaccinations in children, including those recovering from cancer.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a tailored immunization schedule specifically for childhood cancer survivors, a group that often has unique health needs due to their previous treatments. Unlike standard immunization schedules designed for the general population, this approach accounts for the compromised immune systems many survivors may have. By testing different schedules based on age groups, this trial aims to ensure that these young survivors receive the most effective protection possible, ultimately improving their long-term health outcomes.

What evidence suggests that this immunization schedule is effective for childhood cancer survivors?

Research shows that vaccines can be effective for childhood cancer survivors. For instance, one study found that vaccinating children three months after completing cancer treatment helped most develop protection against diseases like measles, mumps, and whooping cough. In this trial, participants will follow an age-based immunization schedule to aid protection after cancer treatment. Many children resume vaccinations after chemotherapy, although timing can vary. These findings support a planned vaccination schedule to protect children post-cancer treatment.678910

Who Is on the Research Team?

NK

Nancy Kernan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors aged 3 to 24 months post-chemotherapy, under 18 at diagnosis. They must be in remission with no active infections or HIV, not pregnant or breastfeeding, and able to consent. Excluded are those with low Karnofsky scores, prior stem cell transplants, vaccine allergies, on immunosuppressants, allergic to latex or who've had Rituximab.

Inclusion Criteria

Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.
I finished my chemotherapy for cancer between 3 to 24 months ago.
My gender or ethnic background does not limit my participation.
See 4 more

Exclusion Criteria

I am HIV positive.
My health status is below 70% on the Karnofsky scale.
I have had a stem cell transplant from myself or a donor.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immunization

Participants receive new immunizations to evaluate their body's response and protection against diseases like measles, mumps, and whooping cough

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness of the immunizations after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Immunization Schedule
Trial Overview The study tests how well new vaccination schedules work for young cancer survivors of different age groups: below 7 years old; between 7 and less than 11 years old; and those aged 11 and above. It aims to establish a standard re-immunization process against diseases like measles.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: CExperimental Treatment1 Intervention
Group II: BExperimental Treatment1 Intervention
Group III: AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

Children with acute lymphocytic leukemia (ALL) experience a temporary reduction in specific antibody levels after intensified chemotherapy, with protection levels for various vaccines ranging from 17% to 100%.
Most children showed a positive response to revaccination, indicating that while chemotherapy affects immunity, their immunological memory is preserved and can be restored with additional vaccinations.
Loss of antibodies and response to (re-)vaccination in children after treatment for acute lymphocytic leukemia: a systematic review.van Tilburg, CM., Sanders, EA., Rovers, MM., et al.[2018]
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]

Citations

Deficits in Long-Term Vaccine Immunity Among Childhood ...The proportion of children exposed to intensive immunosuppression during their primary cancer treatment amounted to 48% for CNS tumors, 66% for ...
Revaccination in Pediatric Oncology Patients: One Center ...This study aimed to share our experience of revaccination in childhood cancer survivors to plan future vaccination schedules.
Immunization Response for Childhood Cancer SurvivorsA study showed that revaccinating childhood cancer survivors three months after completing treatment resulted in protective antibody levels for most vaccines, ...
Optimizing immunization in pediatric oncologyThis study aimed to develop and validate an automated clinical decision support system for generating personalized immunization schedules for pediatric cancer ...
Vaccination in pediatric cancer survivors: Vaccination rates ...Most childhood cancer survivors resume vaccinations postchemotherapy. Considerable variability exists in vaccination timing after chemotherapy.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32706498/
Vaccination in pediatric cancer survivorsVaccination records were available for 82% (98/120) of patients, 57% (56/98) were up to date with vaccinations before chemotherapy, and 83% (81/ ...
4.5 Immunization of Children with CancerContains evidence-informed guidance for the immunization of children with cancer, both during and after immunosuppressive therapy.
Childhood Vaccinations Fact SheetChildren under 2 received vaccines against 7 diseases. These vaccine formulas were safe and effective but complex, targeting more than 3,000 antigens. TODAY.
Vaccination practices of pediatric oncologists from eight statesMore than half (62.7%) recommended that patients restart most immunizations 6 months to 1 year after chemotherapy. Common barriers to providers ...
Historical Vaccine ConcernsIn 2018, a study team including CDC scientists analyzed and published vaccine safety data on adjuvanted pH1N1 vaccines (arenaprix-AS03, Focetria ...
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