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

NCT01016548 | Completed Phase 3

• 2 other identifiers: 09-0780-CINVC-2009-0241
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Seroconversion rates.

  Day 0, 21, 42

Secondary Outcomes (1)

• Adverse events to vaccination.

  Day 7, 21, 28.

Study Arms (2)

Two doses of vaccine

EXPERIMENTAL

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 of vaccine

ACTIVE COMPARATOR

Given at baseline only.

Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine

Interventions

AS03-adjuvanted H1N1 pandemic influenza vaccine BIOLOGICAL

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Also known as: Arepanrix(R), ATC Code J07BB02

One dose of vaccine; Two doses of vaccine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (6)

• Carter NJ, Plosker GL. Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix]: a review of its use as an active immunization against influenza A subtype H5N1 virus. BioDrugs. 2008;22(5):279-92. doi: 10.2165/00063030-200822050-00001.

  PMID: 18778110 BACKGROUND

• Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.

  PMID: 19745216 BACKGROUND

• Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.

  PMID: 19745215 BACKGROUND

• Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.

  PMID: 19846844 BACKGROUND

• Mazza JJ, Yale SH, Arrowood JR, Reynolds CE, Glurich I, Chyou PH, Linneman JG, Reed KD. Efficacy of the influenza vaccine in patients with malignant lymphoma. Clin Med Res. 2005 Nov;3(4):214-20. doi: 10.3121/cmr.3.4.214.

  PMID: 16303886 BACKGROUND

• Ljungman P, Nahi H, Linde A. Vaccination of patients with haematological malignancies with one or two doses of influenza vaccine: a randomised study. Br J Haematol. 2005 Jul;130(1):96-8. doi: 10.1111/j.1365-2141.2005.05582.x.

  PMID: 15982350 BACKGROUND

Related Links

• Arepanrix(R) Product Information Leaflet

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Influenza, Human

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• John Kuruvilla, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

CA (1)