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

NCT01563263 | Completed Phase 2 DMC

• 1 other identifier: IC43-202
• Study Type: interventional
• Target: 803
• Locations: 6 countries
• Sites: 50

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.

Conditions

Pseudomonas Aeruginosa Infection

Keywords

IC43; Pseudomonas Aeruginosa; mechanically ventilated ICU patients; ICU patients

Outcome Measures

Primary Outcomes (1)

• number of deaths until Day 28

  until Day 28

Secondary Outcomes (18)

• number of deaths in comparison on Day 14, 56 and 90

  until Day 90

• number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo

  until Day 90

• number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo

  until Day 90

• number of overall survival in all patients and in patients surviving Day 14

  until Day 180

• number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo

  until Day 90

Study Arms (2)

IC43 100 mcg

ACTIVE COMPARATOR

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

Biological: IC43

Placebo

PLACEBO COMPARATOR

phosphate buffered saline solution containing 0,9 % NaCL

Drug: Placebo

Interventions

IC43 BIOLOGICAL

100 mcg

Also known as: Pseudomonas Aeruginosa

IC43 100 mcg

Placebo DRUG

phosphate buffered saline (PBS) solution containing 0,9 % NaCl

Also known as: phosphate buffered saline (PBS)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (50)

LKH - University Clinic Graz

Graz, Graz, 8036, Austria

Location

LKH Salzburg

Salzburg, Salzburg, 5050, Austria

Location

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Otto Wagner Spital

Vienna, Vienna, 1140, Austria

Location

Wilhelminenspital & Kaiserin-Elisabeth-Spital

Vienna, Vienna, 1160, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

ULB Hospital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

University Hospital Brussels

Brussels, Brussels Capital, 1090, Belgium

Location

Hospital Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Ziekenhuis Oost Limburg

Genk, Genk, 3600, Belgium

Location

University Hospital Ghent

Ghent, Ghent, 9000, Belgium

Location

Clinique St. Pierre

Ottignies, Ottignies, 1340, Belgium

Location

Faculty Hospital St. Ann

Brno, Brno, 65691, Czechia

Location

Faculty Hospital

Hradec Krakove, Hradec Krakove, 50005, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, Prague, 10034, Czechia

Location

Faculty Hospital Motol

Prague, Prague, 15006, Czechia

Location

Central Military Hospital

Prague, Prague, 16902, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, Czechia

Location

Krajská nemocnice T. Bati, a.s.

Zlín, Czechia

Location

HELIOS Klinikum Aue

Aue, Aue, 08280, Germany

Location

Carl-Thiem-Klinikum Cottbus

Cottbus, Cottbus, 03048, Germany

Location

Städtisches Klinikum Dessau

Dessau, Dessau-Roßlau, 06847, Germany

Location

Klinikum Dortmund

Dortmund, Dortmund, 44145, Germany

Location

Neurologische Universitätsklinik

Dresden, Dresden, 01307, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, Erfurt, 99089, Germany

Location

Helios Kreikrankenhaus Gotha/Ohrdruf

Gotha, Gotha, 99867, Germany

Location

Bermannstrost BG Kliniken Halle

Halle, Halle/Saale, 06112, Germany

Location

Saarland University Hospital

Homburg/Saar, Homburg/Saar, 66421, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Kiel, 24105, Germany

Location

Klinikum rechts der Isar

München, München, 81675, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, State of Berlin, 13125, Germany

Location

Charite-Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

HELIOS Klinikum Wuppertal

Wuppertal, Wuppertal, 42283, Germany

Location

St. Imre Hospital

Budapest, Budapest, 1115, Hungary

Location

Uzsoki Hospital

Budapest, Budapest, 1145, Hungary

Location

Kenezy Korhaz Debrecen

Debrecen, Debrecen, 4043, Hungary

Location

Debreceni Egyetem OEC Kazincbarcikai Korhaz

Kazincbarcika, Kazincbarcika, 3700, Hungary

Location

Flor Ferenc Korhaz Hospital

Kistarcsa, Kistarcsa, 2143, Hungary

Location

University of Pecs

Pécs, Pecs, 7623, Hungary

Location

University of Szeged

Szeged, Szeged, 6725, Hungary

Location

Fejer County Hospital

Székesfehérvár, Szekesfehervar, 8000, Hungary

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, 1122, Hungary

Location

Pécsi Tudományegyetem Neurológiai Klinika

Pécs, Hungary

Location

Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario de Getafe

Madrid, Madrid, 28905, Spain

Location

University Hospital Marques de Valdecilla

Santander Cantabria, Santander Cantabria, 39008, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, 46022, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Hospital Universitario y Policlínico La Fe

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 32131866 DERIVED

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Susanne Eder, Mag

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 26, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

AU (6); BE (6); HU (10); DE (14); ES (7); CZ (7)