Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
1 other identifier
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2025
CompletedJune 15, 2025
June 1, 2024
17.9 years
July 18, 2007
June 12, 2025
Conditions
Keywords
Outcome Measures
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.
conclusion of study
Secondary Outcomes (1)
To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.
conclusion of study
Study Arms (3)
A
OTHERImmunization Schedule patients \<7 years.
B
OTHERImmunization Schedule patients \> or = to 7 years and \<11 years of age
C
OTHERImmunization Schedule patients \> or = to 11 years of age
Interventions
* 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.
* 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.
* 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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Kernan, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
July 10, 2007
Primary Completion
June 11, 2025
Study Completion
June 11, 2025
Last Updated
June 15, 2025
Record last verified: 2024-06