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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016548
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : June 4, 2010
Princess Margaret Hospital, Canada
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma Influenza A Virus, H1N1 Subtype Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: Two doses of vaccine
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
One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.
Other Names:
  • Arepanrix(R)
  • ATC Code J07BB02
Active Comparator: One dose of vaccine
Given at baseline only.
Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine
One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.
Other Names:
  • Arepanrix(R)
  • ATC Code J07BB02

Primary Outcome Measures :
  1. Seroconversion rates. [ Time Frame: Day 0, 21, 42 ]

Secondary Outcome Measures :
  1. Adverse events to vaccination. [ Time Frame: Day 7, 21, 28. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016548

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: John Kuruvilla, MD Princess Margaret Hospital, Canada

Additional Information:
Responsible Party: John Kuruvilla, MD, Princess Margaret Hospital Identifier: NCT01016548     History of Changes
Other Study ID Numbers: 09-0780-C
INVC-2009-0241 ( Other Identifier: Ontario Agency for Health Protection and Promotion )
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010

Keywords provided by University Health Network, Toronto:
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Influenza A Virus, H1N1 Subtype
Influenza Vaccines
Bone Marrow Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Influenza, Human
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs