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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

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.

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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.

Conditions

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Lymphoma Multiple Myeloma Influenza A Virus, H1N1 Subtype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Two doses of vaccine

Second dose is given 21 days after the initial dose. The same dose and route of administration are used.

Group Type EXPERIMENTAL

AS03-adjuvanted H1N1 pandemic influenza vaccine

Intervention Type BIOLOGICAL

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

One dose of vaccine

Given at baseline only.

Group Type ACTIVE_COMPARATOR

AS03-adjuvanted H1N1 pandemic influenza vaccine

Intervention Type BIOLOGICAL

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Interventions

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AS03-adjuvanted H1N1 pandemic influenza vaccine

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Intervention Type BIOLOGICAL

Other Intervention Names

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Arepanrix(R) ATC Code J07BB02

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No