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

Phase 3

Completed

• Conditions: Lymphoma; Multiple Myeloma; Influenza A Virus, H1N1 Subtype
• Interventions: Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine

• Registration Number: NCT01016548
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-18
• Study First Posted: 2009-11-19
• Primary Completion: 2010-03
• Status Verified: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Two doses of vaccine	AS03-adjuvanted H1N1 pandemic influenza vaccine	Second dose is given 21 days after the initial dose. The same dose and route of administration are used.
One dose of vaccine	AS03-adjuvanted H1N1 pandemic influenza vaccine	Given at baseline only.

Primary Outcome Measures

Name	Time	Method
Seroconversion rates.	Day 0, 21, 42

Secondary Outcome Measures

Name	Time	Method
Adverse events to vaccination.	Day 7, 21, 28.

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada