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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016548
• Other study ID #: 09-0780-C
• Secondary ID: INVC-2009-0241
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2009
• Last updated: June 3, 2010
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Influenza A Virus, H1N1 Subtype
• Influenza, Human
• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• AS03-adjuvanted H1N1 pandemic influenza vaccine
One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rates.		Day 0, 21, 42	No
Secondary	Adverse events to vaccination.		Day 7, 21, 28.	Yes

External Links

•   Arepanrix(R) Product Information Leaflet