Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia. PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.

Detailed Description
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OBJECTIVES: Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine. Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination. OUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months). Patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses. Patients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9. PROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.

Official Title
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Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia

Conditions
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Infection, Leukemia

Intervention / Treatment
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* Biological: trivalent influenza vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia In first remission after completion of induction chemotherapy Currently on active treatment OR Completed treatment within the past 6 months PATIENT CHARACTERISTICS: Age: 1 to 20 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No acute respiratory distress Other: No history of Guillain-Barre syndrome No history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal No febrile illness with fever over 100.4 degrees F Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trivalent influenza vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood acute lymphoblastic leukemia in remission, infection