Reducing the Burden of Influenza After Solid-Organ Transplantation: the STOP-FLU Trial [Swiss Trial in Solid Organ Transplantation on Prevention of Influenza]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 619
- 试验地点
- 18
- 主要终点
- Vaccine response rate
研究概览
简要总结
Influenza is associated with significant morbidity and mortality in solid-organ transplant (SOT) recipients and it is mainly prevented by seasonal influenza vaccination. Unfortunately, the immunogenicity of standard influenza vaccine is suboptimal in this population. Vaccination with a high-dose (HD) influenza vaccine or an MF59-adjuvanted (MF59a) vaccine have significantly reduced the incidence of influenza and increased the immunogenicity of influenza vaccine in the elderly. The investigators will compare the immunogenicity and efficacy of two new vaccination strategies, consisting in vaccination with a HD influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of SOT recipients.
详细描述
Objectives: The primary objective of this study is to compare the immunogenicity of two novel vaccination strategies, consisting in vaccination with a HD influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of SOT recipients.
The main secondary objectives are to evaluate the efficacy of the novel vaccination strategies in reducing the incidence of influenza, to correlate the humoral responses to vaccination with protection from influenza and to assess the influence of immunosuppression on influenza vaccine responses.
Safety objectives include the assessment of the reactogenicity of the different vaccines and to describe the incidence of acute rejection and the development of anti-Human Leucocyte Antigens (HLA) antibodies after vaccination.
Study design: Prospective double-blinded randomized controlled three-arm parallel group superiority multicenter trial.
Inclusion / Exclusion criteria: Study participants will be enrolled among ≥18-year old stable SOT recipients ≥3 months after transplantation, regularly followed at their respective outpatient clinic at the 7 transplant centers and scheduled to receive the annual influenza vaccine. Candidates will be excluded in case of previous severe reaction or allergy to one of the study vaccines or in case of treatment for acute rejection, among others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written, informed consent
- •Age ≥18 years
- •Stable outpatients based on clinical judgement
- •≥ 3 months after solid organ transplantation
排除标准
- •Known hypersensitivity to any component (antigen, adjuvant, excipient or preservative) of study vaccines; the composition of the study vaccines is as follows:
- •VaxigripTetra®: hemagglutinin, egg protein, formaldehyde, octylphenol ethoxylate/octoxynol 9 (Triton® X-100), neomycin
- •Fluad®: hemagglutinin, neuraminidase, egg protein, squalene, polysorbate 80, sorbitan trioleate, sodium citrate, citric acid, kanamycin sulphate, neomycin sulphate, barium sulphate, formaldehyde, cetyl trimethylammonium bromide
- •Fluzone-HD®: hemagglutinin, egg protein, formaldehyde, octylphenol ethoxylate/octoxynol 9 (Triton® X-100)
- •Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barré Syndrome)
- •Ongoing therapy for rejection (including steroid pulse or prednisone > 2mg/kg/day over more than 14 days)
- •Ongoing therapy with intravenous immunoglobulin (IVIG) and/or eculizumab
- •Current or past (within 6 months) therapy with rituximab
- •Abo incompatible transplantation
- •Unable to comply with study protocol
- •Pregnancy or breastfeeding
结局指标
主要结局
Vaccine response rate
时间窗: day 28 after vaccination
Seroconversion rate for at least one viral antigen
次要结局
- Reactogenicity(within 28 days after vaccination)
- Influenza infection(Within 6 month after vaccination)
- Seroprotection rates(At day 28 and month 6 after vaccination)
- Development of anti-HLA antibodies(Within 6 months post vaccination)
研究者
Oriol Manuel
Principal Investigator
University of Lausanne Hospitals