Clinical Trial: Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Valneva Austria GmbH

Current Primary Outcome: number of deaths until Day 28 [ Time Frame: until Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of deaths in comparison on Day 14, 56 and 90 [ Time Frame: until Day 90 ]
  • number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of overall survival in all patients and in patients surviving Day 14 [ Time Frame: until Day 180 ]
  • number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of surviving subjects after Sepsis receiving IC43 or placebo [ Time Frame: until Day 180 ]
  • number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180 [ Time Frame: until Day 180 ]
  • 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 [ Time Frame: until Day 56 ]
  • 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 [ Time Frame: until Day 56 ]
  • Organ function in patients receiving IC43 or placebo during ICU stay [ Time Frame: during ICU stay ]
  • Days of ICU stay in patients receiving IC43 or placebo [ Time Frame: 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 [ Time Frame: until Day 180 ]
  • Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [ Time Frame: until Day 180 ]
  • systemic tolerability [ Time Frame: until Day 7 ]
    blood pressure
  • number of local reactions at the injection site [ Time Frame: until Day 180 ]
  • Composite measure of laboratory parameters [ Time Frame: until Day 56 ]
  • systemic tolerability [ Time Frame: until Day 7 ]
    pulse
  • systemic tolerability [ Time Frame: until Day 7 ]
    body temperature


Original Secondary Outcome:

  • number of deaths in comparison on Day 14, 56 and 90 [ Time Frame: until Day 90 ]
  • number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of overall survival in all patients and in patients surviving Day 14 [ Time Frame: until Day 180 ]
  • number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo [ Time Frame: until Day 90 ]
  • number of surviving subjects after Sepsis receiving IC43 or placebo [ Time Frame: until Day 180 ]
  • number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180 [ Time Frame: until Day 180 ]
  • 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 [ Time Frame: until Day 56 ]
  • 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 [ Time Frame: until Day 56 ]
  • Organ function in patients receiving IC43 or placebo during ICU stay [ Time Frame: during ICU stay ]
  • Days of ICU stay in patients receiving IC43 or placebo [ Time Frame: 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 [ Time Frame: until Day 180 ]
  • Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [ Time Frame: until Day 180 ]
  • systemic tolerability (blood pressure in mmHg, pulse in bpm, body temperature in °C) [ Time Frame: until Day 7 ]
    blood pressure, pulse, body temperature
  • number of local reactions at the injection site [ Time Frame: until Day 180 ]
  • safety laboratory parameters (unit depends on parameter) [ Time Frame: until Day 56 ]
    hematology: Hemoglobin, hematocrit, erythrocyte count, white blood count, platelets Chemistry: creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), c-reactive protein (CRP)


Information By: Valneva Austria GmbH

Dates:
Date Received: March 14, 2012
Date Started: March 2012
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016