Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
NCT ID: NCT00505063
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2007-07-10
2025-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Immunization Schedule patients \<7 years.
Immunization Schedule patients <7 years.
* 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.
B
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients > or = to 7 years and <11 years of age
* 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.
C
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients > or = to 11 years of age
* 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)
Interventions
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Immunization Schedule patients <7 years.
* 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.
Immunization Schedule patients > or = to 7 years and <11 years of age
* 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.
Immunization Schedule patients > or = to 11 years of age
* 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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
1. For patients \<12 months following completion of therapy, CR must be documented within 3 months of enrollment.
2. 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
* 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.
2 Years
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy Kernan, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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07-088
Identifier Type: -
Identifier Source: org_study_id
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