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

Sponsor
Valneva Austria GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT01563263
Collaborator
(none)
803
Enrollment
50
Locations
2
Arms
45
Duration (Months)
16.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: IC43
  • Drug: Placebo
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
803 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: IC43 100 mcg

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

Biological: IC43
100 mcg
Other Names:
  • 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 Names:
  • phosphate buffered saline (PBS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of deaths until Day 28 [until Day 28]

    Secondary Outcome Measures

    1. number of deaths in comparison on Day 14, 56 and 90 [until Day 90]

    2. number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo [until Day 90]

    3. number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo [until Day 90]

    4. number of overall survival in all patients and in patients surviving Day 14 [until Day 180]

    5. number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo [until Day 90]

    6. number of surviving subjects after Sepsis receiving IC43 or placebo [until Day 180]

    7. number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180 [until Day 180]

    8. 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]

    9. 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]

    10. Organ function in patients receiving IC43 or placebo during ICU stay [during ICU stay]

    11. Days of ICU stay in patients receiving IC43 or placebo [Until Day 180]

    12. 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]

    13. Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [until Day 180]

    14. systemic tolerability [until Day 7]

      blood pressure

    15. number of local reactions at the injection site [until Day 180]

    16. Composite measure of laboratory parameters [until Day 56]

    17. systemic tolerability [until Day 7]

      pulse

    18. systemic tolerability [until Day 7]

      body temperature

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 LKH - University Clinic Graz Graz Austria 8036
    2 LKH Salzburg Salzburg Austria 5050
    3 Medical University of Vienna Vienna Austria 1090
    4 Krankenhaus Hietzing Vienna Austria 1130
    5 Otto Wagner Spital Vienna Austria 1140
    6 Wilhelminenspital & Kaiserin-Elisabeth-Spital Vienna Austria 1160
    7 ULB Hospital Erasme Brussels Belgium 1070
    8 University Hospital Brussels Brussels Belgium 1090
    9 Hospital Saint Luc Brussels Belgium 1200
    10 Ziekenhuis Oost Limburg Genk Belgium 3600
    11 University Hospital Ghent Ghent Belgium 9000
    12 Clinique St. Pierre Ottignies Belgium 1340
    13 Faculty Hospital St. Ann Brno Czech Republic 65691
    14 Faculty Hospital Hradec Krakove Czech Republic 50005
    15 Fakultní nemocnice Olomouc Olomouc Czech Republic
    16 Faculty Hospital Kralovske Vinohrady Prague Czech Republic 10034
    17 Faculty Hospital Motol Prague Czech Republic 15006
    18 Central Military Hospital Praha Czech Republic 16902
    19 Krajská nemocnice T. Bati, a.s. Zlín Czech Republic
    20 HELIOS Klinikum Aue Aue Germany 08280
    21 HELIOS Klinikum Berlin-Buch Berlin Germany 13125
    22 Charite-Universitätsmedizin Berlin Berlin Germany 13353
    23 Carl-Thiem-Klinikum Cottbus Cottbus Germany 03048
    24 Städtisches Klinikum Dessau Dessau-Roßlau Germany 06847
    25 Klinikum Dortmund Dortmund Germany 44145
    26 Neurologische Universitätsklinik Dresden Germany 01307
    27 HELIOS Klinikum Erfurt Erfurt Germany 99089
    28 Helios Kreikrankenhaus Gotha/Ohrdruf Gotha Germany 99867
    29 Bermannstrost BG Kliniken Halle Halle/Saale Germany 06112
    30 Saarland University Hospital Homburg/Saar Germany 66421
    31 Universitätsklinikum Schleswig-Holstein Kiel Germany 24105
    32 Klinikum rechts der Isar München Germany 81675
    33 HELIOS Klinikum Wuppertal Wuppertal Germany 42283
    34 St. Imre Hospital Budapest Hungary 1115
    35 Országos Korányi TBC és Pulmonológiai Intézet Budapest Hungary 1122
    36 Uzsoki Hospital Budapest Hungary 1145
    37 Kenezy Korhaz Debrecen Debrecen Hungary 4043
    38 Debreceni Egyetem OEC Kazincbarcikai Korhaz Kazincbarcika Hungary 3700
    39 Flor Ferenc Korhaz Hospital Kistarcsa Hungary 2143
    40 University of Pecs Pecs Hungary 7623
    41 Pécsi Tudományegyetem Neurológiai Klinika Pécs Hungary
    42 University of Szeged Szeged Hungary 6725
    43 Fejer County Hospital Szekesfehervar Hungary 8000
    44 Hospital Universitario Infanta Cristina Badajoz Spain
    45 Vall d'Hebron University Hospital Barcelona Spain 08035
    46 Hospital Clinico San Carlos Madrid Spain 28040
    47 Hospital Universitario de Getafe Madrid Spain 28905
    48 University Hospital Marques de Valdecilla Santander Cantabria Spain 39008
    49 Hospital Universitario Dr. Peset Valencia Spain 46022
    50 Hospital Universitario y Policlínico La Fe Valencia Spain

    Sponsors and Collaborators

    • Valneva Austria GmbH

    Investigators

    • Study Chair: Susanne Eder, Mag, Valneva Austria GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Valneva Austria GmbH
    ClinicalTrials.gov Identifier:
    NCT01563263
    Other Study ID Numbers:
    • IC43-202
    First Posted:
    Mar 26, 2012
    Last Update Posted:
    Mar 31, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Valneva Austria GmbH
    IC43
    Pseudomonas Aeruginosa
    mechanically ventilated ICU patients
    ICU patients
    Additional relevant MeSH terms:
    Pseudomonas Infections

    Study Results

    No Results Posted as of Mar 31, 2016