Childhood Cancer, Multiple Diseases
Conditions
Keywords
vaccine, childhood, cancer
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.
Interventions
BIOLOGICALImmunization 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.
BIOLOGICALImmunization 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.
BIOLOGICALImmunization 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)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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. 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Protective Antibody Titers After Vaccination | Up to 2 years | To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline | Baseline | The Absolute Lymphocyte Count (ALC), the absolute CD4+ T cell count, and the absolute CD8+ T cell count at baseline were the in-vitro parameters of lymphoid reconstitution. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Kernan, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 9.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Region of Enrollment United States | 36 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 13 | 0 / 36 |
| other Total, other adverse events | 0 / 26 | 0 / 13 | 0 / 36 |
| serious Total, serious adverse events | 0 / 26 | 0 / 13 | 1 / 36 |
Outcome results
None listed