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Completed

NCT Number: NCT00505063

Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

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.

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Key information

Conditions

Childhood Cancer Multiple Diseases Neoplasms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be < or less 18 years of age at cancer diagnosis
  • Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
  • For patients <12 months following completion of therapy, CR must be documented within 3 months of enrollment.
  • For patients >12 months, CR must be documented at approximately 12 months and then only as clinically indicated

i. For patients with leukemia: bone marrow aspirate defined as <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be determined by appropriate radiologic scans, and other tests, including bone marrow aspirate and biopsies demonstrating absence of extrinsic cells and absence of specific FISH or cytogenetic abnormality (if applicable), iii. For patients with lymphoma, remission will be determined by bone marrow aspirate and biopsy, radiologic scans and other tests. Bone marrow will show <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable), and flow cytometry (if lymphoma specific marker present) and absence of CNS disease by spinal fluid (if applicable)

  • Patient may be of either gender and of any ethnic background
  • 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

  • Karnofsky score <70%.
  • Female patients who are pregnant or lactating.
  • Patients who have received an autologous or allogeneic HCT.
  • Active uncontrolled bacterial or fungal infection.
  • Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
  • Patients on any immunosuppressive drugs.
  • HIV-1,2 sero-positive patients.
  • Patients or guardians not signing informed consent.
  • Patients with prior allergic reaction to any vaccine component or to latex.
  • Patients who have received Rituximab.

Treatment and study plan

Immunization Schedule patients <7 years.

Biological
  • Time 0 months: Prevnar 13 #1, Hib #1
  • Time 1 months: Pediarix #1
  • Time 2 months: Prevnar 13 #2, Hib #2
  • Time 3-4 months: Pediarix #2
  • Time 4-6 months: Draw post vaccine titers
  • Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.

Other names: vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax, Quadrivalent HPV Recombinant Vaccine

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

Biological
  • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
  • Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
  • Time 2-3 months: Prevnar 13 #2, Hib #2
  • Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.

Other names: vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax, Quadrivalent HPV Recombinant Vaccine

Immunization Schedule patients > or = to 11 years of age

Biological
  • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
  • Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
  • Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
  • Time 3-6 months: IPV, Draw post vaccine titers
  • Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)

Primary outcomes

  1. To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.

    Time frame: conclusion of study

Secondary outcomes

  1. To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Important dates

Study start
2007
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2007
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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