Immunization Response for Childhood Cancer Survivors

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressive drugs, Rituximab

Disqualifiers: Pregnancy, HIV, HCT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will look at your body's response to the new immunizations. We want to see how well they will protect you. Immunization is the same as vaccination. Our goal is to protect you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We are doing the study because there is no standard way to re-immunize people after cancer treatments.

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.

What data supports the effectiveness of the treatment Immunization Schedule for childhood cancer survivors?

A study showed that revaccinating childhood cancer survivors three months after completing treatment resulted in protective antibody levels for most vaccines, indicating that a tailored immunization schedule can be effective for these patients. ^{1 2 3 4 5}

Is it safe for childhood cancer survivors to receive vaccinations after treatment?

Research shows that revaccinating childhood cancer survivors after treatment is generally safe and can help restore protective antibody levels. Most patients respond well to revaccination, indicating their immune systems can recover and handle vaccines safely. ^{2 3 4 6 7}

How is the Immunization Schedule treatment unique for childhood cancer survivors?

The Immunization Schedule for childhood cancer survivors is unique because it uses a response-based approach to tailor vaccine schedules, starting vaccinations 3 months after treatment ends to ensure protective antibody levels, unlike standard guidelines which are not universally approved. ^{1 2 3 4 8}

Research Team

Nancy Kernan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

I finished my chemotherapy for cancer between 3 to 24 months ago.

My gender or ethnic background does not limit my participation.

Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: C Experimental Treatment 1 Intervention

Immunization Schedule patients \> or = to 11 years of age

Group II: B Experimental Treatment 1 Intervention

Immunization Schedule patients \> or = to 7 years and \<11 years of age

Group III: A Experimental Treatment 1 Intervention

Immunization Schedule patients \<7 years.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study. Han, JH., Harmoney, KM., Dokmeci, E., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vaccination in pediatric cancer survivors: Vaccination rates, immune status, and knowledge regarding compliance. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study. [2018]

3. Singapore pubmed.ncbi.nlm.nih.gov

Immunization status in childhood cancer survivors: A hidden risk which could be prevented. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

How to manage vaccinations in children with cancer. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Influenza immunization in immunosuppressed children. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Loss of antibodies and response to (re-)vaccination in children after treatment for acute lymphocytic leukemia: a systematic review. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

Adapting immunisation schedules for children undergoing chemotherapy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Survivors of childhood cancer: an Australian audit of vaccination status after treatment. [2015]