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临床试验/NCT01016548
NCT01016548已完成3 期

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

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Seroconversion rates.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Two doses of vaccine

Experimental

Second dose is given 21 days after the initial dose. The same dose and route of administration are used.

干预措施: AS03-adjuvanted H1N1 pandemic influenza vaccine (Biological)

One dose of vaccine

Active Comparator

Given at baseline only.

干预措施: AS03-adjuvanted H1N1 pandemic influenza vaccine (Biological)

结局指标

主要结局

Seroconversion rates.

时间窗: Day 0, 21, 42

次要结局

  • Adverse events to vaccination.(Day 7, 21, 28.)

研究者

申办方类型
Other

研究点 (1)

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