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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01016548
First received: November 18, 2009
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Seroconversion rates. [ Time Frame: Day 0, 21, 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events to vaccination. [ Time Frame: Day 7, 21, 28. ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016548

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

Additional Information:
Publications:
Responsible Party: John Kuruvilla, MD, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT01016548     History of Changes
Other Study ID Numbers: 09-0780-C, INVC-2009-0241
Study First Received: November 18, 2009
Last Updated: June 3, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Influenza, Human
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 20, 2014