Clinical trial NCT01016548: Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy
Official title: Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma
Multiple Myeloma
Influenza A Virus, H1N1 Subtype
Keywords: Lymphoma
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Influenza A Virus, H1N1 Subtype
Influenza Vaccines
Bone Marrow Transplantation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2009-11-19
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Seroconversion rates.
timeFrame: Day 0, 21, 42
Secondary outcomes:
measure: Adverse events to vaccination.
timeFrame: Day 7, 21, 28.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: John Kuruvilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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