Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.

Detailed Description
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The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009 (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with hematologic disorders are at high risk of influenza-related complications, including death. Given that the vaccination dosing for the pandemic vaccine has been developed on healthy individuals, it is unknown whether this subgroup of patients will respond similarly. We will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid malignancies receiving active systemic treatment, or who have recently undergone stem cell transplantation. Patients will be randomized to one or two doses of the approved adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also, we will look for an association between biomarkers of the immune system and a response to the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow cytometry.

Official Title
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Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation

Conditions
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Lymphoma, Multiple Myeloma, Influenza A Virus, H1N1 Subtype

Intervention / Treatment
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* Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ages 20-65 Diagnosis of lymphoproliferative disorder One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months Able to provide consent and comply with trial requirements Exclusion Criteria: Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin History of life-threatening reaction to prior influenza vaccination Thrombocytopenia or bleeding disorder contraindicating IM injection Pregnancy Laboratory-confirmed infection with H1N1(2009) IVIG infusion within the last three months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two doses of vaccine<br>Second dose is given 21 days after the initial dose. The same dose and route of administration are used. | Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine<br>* One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.<br>* Other names: ATC Code J07BB02;|
| Active Comparator: One dose of vaccine<br>Given at baseline only. | Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine<br>* One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.<br>* Other names: ATC Code J07BB02;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rates. |  | Day 0, 21, 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events to vaccination. |  | Day 7, 21, 28. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Multiple myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Influenza A Virus, H1N1 Subtype, Influenza Vaccines, Bone Marrow Transplantation