A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 803
- 试验地点
- 50
- 主要终点
- number of deaths until Day 28
研究概览
简要总结
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
详细描述
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent (i.e., from the patient or from the patient's legally authorized representative) or waiver will be obtained according to regional requirements prior to any study related procedures. Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU discharge occurs before Day 7, immunization will be done at the hospital ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0
- •written informed consent or waiver according to the national regulations
- •no childbearing potential or negative pregnancy test
排除标准
- •Sequential Organ Failure Assessment (SOFA) < 4 on Day 0
- •Patients <6 months post organ transplantation
- •readmission to ICU during the current total hospital stay on Day 0
- •patients admitted to ICU within 2 days after surgery
- •patients admitted to ICU due to trauma
- •elective surgery until Day 28 after first vaccination
研究组 & 干预措施
Placebo
phosphate buffered saline solution containing 0,9 % NaCL
干预措施: Placebo (Drug)
IC43 100 mcg
IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein
干预措施: IC43 (Biological)
结局指标
主要结局
number of deaths until Day 28
时间窗: until Day 28
次要结局
- number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo(until Day 90)
- percentage of patients with invasive infection with P. aeruginosa, such as bacteremia or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo up to Day 56 after first vaccination(until Day 56)
- Organ function in patients receiving IC43 or placebo during ICU stay(during ICU stay)
- Days of ICU stay in patients receiving IC43 or placebo(Until Day 180)
- number of deaths in comparison on Day 14, 56 and 90(until Day 90)
- number of overall survival in all patients and in patients surviving Day 14(until Day 180)
- Composite measure of laboratory parameters(until Day 56)
- number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo(until Day 90)
- number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo(until Day 90)
- number of surviving subjects after Sepsis receiving IC43 or placebo(until Day 180)
- number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180(until Day 180)
- Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo(until Day 180)
- Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination(until Day 180)
- number of local reactions at the injection site(until Day 180)
- systemic tolerability(until Day 7)
- percentage of patients with P. aeruginosa respiratory tract infection or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo up to Day 56 after first vaccination(until Day 56)