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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Valneva Austria GmbH
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01563263
First received: March 14, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Pseudomonas Aeruginosa Infection
Biological: IC43
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • number of deaths until Day 28 [ Time Frame: until Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of deaths in comparison on Day 14, 56 and 90 [ Time Frame: until Day 90 ] [ Designated as safety issue: No ]
  • number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo [ Time Frame: until Day 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • number of overall survival in all patients and in patients surviving Day 14 [ Time Frame: until Day 180 ] [ Designated as safety issue: No ]
  • number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo [ Time Frame: until Day 90 ] [ Designated as safety issue: No ]
  • number of surviving subjects after Sepsis receiving IC43 or placebo [ Time Frame: until Day 180 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Organ function in patients receiving IC43 or placebo during ICU stay [ Time Frame: during ICU stay ] [ Designated as safety issue: No ]
  • Days of ICU stay in patients receiving IC43 or placebo [ Time Frame: Until Day 180 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [ Time Frame: until Day 180 ] [ Designated as safety issue: Yes ]
  • systemic tolerability [ Time Frame: until Day 7 ] [ Designated as safety issue: Yes ]
    blood pressure

  • number of local reactions at the injection site [ Time Frame: until Day 180 ] [ Designated as safety issue: Yes ]
  • safety laboratory parameters [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]
  • systemic tolerability [ Time Frame: until Day 7 ] [ Designated as safety issue: Yes ]
    pulse

  • systemic tolerability [ Time Frame: until Day 7 ] [ Designated as safety issue: Yes ]
    body temperature


Estimated Enrollment: 800
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC43 100 mcg
IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein
Biological: IC43
100 mcg
Other Name: Pseudomonas Aeruginosa
Placebo Comparator: Placebo
phosphate buffered saline solution containing 0,9 % NaCL
Drug: Placebo
phosphate buffered saline (PBS) solution containing 0,9 % NaCl
Other Name: phosphate buffered saline (PBS)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563263

Contacts
Contact: Susanne Eder, Mag. 0043 1 206 20 ext 0 info@valneva.com

  Show 55 Study Locations
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Chair: Susanne Eder, Mag Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01563263     History of Changes
Other Study ID Numbers: IC43-202
Study First Received: March 14, 2012
Last Updated: September 11, 2014
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Hungary: Institutional Ethics Committee
Hungary: Ministry of Health, Social and Family Affairs
Spain: Ethics Committee
Spain: Ministry of Health

Keywords provided by Valneva Austria GmbH:
IC43
Pseudomonas Aeruginosa
mechanically ventilated ICU patients
ICU patients

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014