Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Study Overview
=================
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.

Official Title
-----------------
Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Conditions
-----------------
Childhood Cancer, Multiple Diseases

Intervention / Treatment
-----------------
* Biological: Immunization Schedule patients <7 years.
* Biological: Immunization Schedule patients > or = to 7 years and <11 years of age
* Biological: Immunization Schedule patients > or = to 11 years of age


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Immunization Schedule patients <7 years. | Biological: Immunization Schedule patients <7 years.<br>* 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.<br>* Other names: Quadrivalent HPV Recombinant Vaccine;|
| Other: B<br>Immunization Schedule patients > or = to 7 years and <11 years of age | Biological: Immunization Schedule patients > or = to 7 years and <11 years of age<br>* 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.<br>* Other names: Quadrivalent HPV Recombinant Vaccine;|
| Other: C<br>Immunization Schedule patients > or = to 11 years of age | Biological: Immunization Schedule patients > or = to 11 years of age<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response. |  | conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, childhood, cancer