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

June 3, 2010 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion rates.
Time Frame: Day 0, 21, 42
Day 0, 21, 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events to vaccination.
Time Frame: Day 7, 21, 28.
Day 7, 21, 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: John Kuruvilla, MD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (ESTIMATE)

November 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2010

Last Update Submitted That Met QC Criteria

June 3, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0780-C
  • INVC-2009-0241 (OTHER: Ontario Agency for Health Protection and Promotion)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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