Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Frequency of responders in organ transplant patients and controls
研究概览
简要总结
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.
详细描述
A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of > 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline.
- •Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.
排除标准
- •Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline.
- •Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.
结局指标
主要结局
Frequency of responders in organ transplant patients and controls
次要结局
- Frequency of >4-fold titre rise in organ transplant patients and controls
研究者
Vanda Friman
MD, PhD
Sahlgrenska University Hospital, Sweden