Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy
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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 |
- Seroconversion rates. [ Time Frame: Day 0, 21, 42 ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
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 |
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| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| 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 June 18, 2013