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

Primary Purpose

Pseudomonas Aeruginosa Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IC43
Placebo
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudomonas Aeruginosa Infection focused on measuring IC43, Pseudomonas Aeruginosa, mechanically ventilated ICU patients, ICU patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH - University Clinic Graz
  • LKH Salzburg
  • Medical University of Vienna
  • Krankenhaus Hietzing
  • Otto Wagner Spital
  • Wilhelminenspital & Kaiserin-Elisabeth-Spital
  • ULB Hospital Erasme
  • University Hospital Brussels
  • Hospital Saint Luc
  • Ziekenhuis Oost Limburg
  • University Hospital Ghent
  • Clinique St. Pierre
  • Faculty Hospital St. Ann
  • Faculty Hospital
  • Fakultní nemocnice Olomouc
  • Faculty Hospital Kralovske Vinohrady
  • Faculty Hospital Motol
  • Central Military Hospital
  • Krajská nemocnice T. Bati, a.s.
  • HELIOS Klinikum Aue
  • HELIOS Klinikum Berlin-Buch
  • Charite-Universitätsmedizin Berlin
  • Carl-Thiem-Klinikum Cottbus
  • Städtisches Klinikum Dessau
  • Klinikum Dortmund
  • Neurologische Universitätsklinik
  • HELIOS Klinikum Erfurt
  • Helios Kreikrankenhaus Gotha/Ohrdruf
  • Bermannstrost BG Kliniken Halle
  • Saarland University Hospital
  • Universitätsklinikum Schleswig-Holstein
  • Klinikum rechts der Isar
  • HELIOS Klinikum Wuppertal
  • St. Imre Hospital
  • Országos Korányi TBC és Pulmonológiai Intézet
  • Uzsoki Hospital
  • Kenezy Korhaz Debrecen
  • Debreceni Egyetem OEC Kazincbarcikai Korhaz
  • Flor Ferenc Korhaz Hospital
  • University of Pecs
  • Pécsi Tudományegyetem Neurológiai Klinika
  • University of Szeged
  • Fejer County Hospital
  • Hospital Universitario Infanta Cristina
  • Vall d'Hebron University Hospital
  • Hospital Clinico San Carlos
  • Hospital Universitario de Getafe
  • University Hospital Marques de Valdecilla
  • Hospital Universitario Dr. Peset
  • Hospital Universitario y Policlínico La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IC43 100 mcg

Placebo

Arm Description

IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein

phosphate buffered saline solution containing 0,9 % NaCL

Outcomes

Primary Outcome Measures

number of deaths until Day 28

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2012
Last Updated
March 29, 2016
Sponsor
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01563263
Brief Title
Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
Official Title
A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomonas Aeruginosa Infection
Keywords
IC43, Pseudomonas Aeruginosa, mechanically ventilated ICU patients, ICU patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC43 100 mcg
Arm Type
Active Comparator
Arm Description
IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
phosphate buffered saline solution containing 0,9 % NaCL
Intervention Type
Biological
Intervention Name(s)
IC43
Other Intervention Name(s)
Pseudomonas Aeruginosa
Intervention Description
100 mcg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
phosphate buffered saline (PBS)
Intervention Description
phosphate buffered saline (PBS) solution containing 0,9 % NaCl
Primary Outcome Measure Information:
Title
number of deaths until Day 28
Time Frame
until Day 28
Secondary Outcome Measure Information:
Title
number of deaths in comparison on Day 14, 56 and 90
Time Frame
until Day 90
Title
number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo
Time Frame
until Day 90
Title
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
Title
number of overall survival in all patients and in patients surviving Day 14
Time Frame
until Day 180
Title
number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo
Time Frame
until Day 90
Title
number of surviving subjects after Sepsis receiving IC43 or placebo
Time Frame
until Day 180
Title
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
Title
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
Title
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
Title
Organ function in patients receiving IC43 or placebo during ICU stay
Time Frame
during ICU stay
Title
Days of ICU stay in patients receiving IC43 or placebo
Time Frame
Until Day 180
Title
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
Title
Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination
Time Frame
until Day 180
Title
systemic tolerability
Description
blood pressure
Time Frame
until Day 7
Title
number of local reactions at the injection site
Time Frame
until Day 180
Title
Composite measure of laboratory parameters
Time Frame
until Day 56
Title
systemic tolerability
Description
pulse
Time Frame
until Day 7
Title
systemic tolerability
Description
body temperature
Time Frame
until Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Eder, Mag
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
LKH - University Clinic Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Salzburg
City
Salzburg
ZIP/Postal Code
5050
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Hietzing
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Otto Wagner Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Wilhelminenspital & Kaiserin-Elisabeth-Spital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
ULB Hospital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hospital Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique St. Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Faculty Hospital St. Ann
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Faculty Hospital
City
Hradec Krakove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Faculty Hospital Motol
City
Prague
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Central Military Hospital
City
Praha
ZIP/Postal Code
16902
Country
Czech Republic
Facility Name
Krajská nemocnice T. Bati, a.s.
City
Zlín
Country
Czech Republic
Facility Name
HELIOS Klinikum Aue
City
Aue
ZIP/Postal Code
08280
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Carl-Thiem-Klinikum Cottbus
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Städtisches Klinikum Dessau
City
Dessau-Roßlau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Klinikum Dortmund
City
Dortmund
ZIP/Postal Code
44145
Country
Germany
Facility Name
Neurologische Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
HELIOS Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Helios Kreikrankenhaus Gotha/Ohrdruf
City
Gotha
ZIP/Postal Code
99867
Country
Germany
Facility Name
Bermannstrost BG Kliniken Halle
City
Halle/Saale
ZIP/Postal Code
06112
Country
Germany
Facility Name
Saarland University Hospital
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
St. Imre Hospital
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Hospital
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Kenezy Korhaz Debrecen
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Debreceni Egyetem OEC Kazincbarcikai Korhaz
City
Kazincbarcika
ZIP/Postal Code
3700
Country
Hungary
Facility Name
Flor Ferenc Korhaz Hospital
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Pécsi Tudományegyetem Neurológiai Klinika
City
Pécs
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Fejer County Hospital
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Hospital Universitario Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
University Hospital Marques de Valdecilla
City
Santander Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Facility Name
Hospital Universitario y Policlínico La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32131866
Citation
Adlbrecht C, Wurm R, Depuydt P, Spapen H, Lorente JA, Staudinger T, Creteur J, Zauner C, Meier-Hellmann A, Eller P, Laenen MV, Molnar Z, Varkonyi I, Schaaf B, Hejja M, Sramek V, Schneider H, Kanesa-Thasan N, Eder-Lingelbach S, Klingler A, Dubischar K, Wressnigg N, Rello J. Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial. Crit Care. 2020 Mar 4;24(1):74. doi: 10.1186/s13054-020-2792-z.
Results Reference
derived

Learn more about this trial

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

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