NCT01016548

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Multiple Myeloma
• Influenza A Virus, H1N1 Subtype

Interventions

Type	Name	Description
BIOLOGICAL	AS03-adjuvanted H1N1 pandemic influenza vaccine	One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-11-19
• Last updated: 2010-06-04

Locations

1 site across 1 country: Canada