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

NCT ID: NCT01563263

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Pseudomonas Aeruginosa Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IC43 100 mcg

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

Group Type: ACTIVE_COMPARATOR

IC43

Intervention Type: BIOLOGICAL

100 mcg

Placebo

phosphate buffered saline solution containing 0,9 % NaCL

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

IC43

100 mcg

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Pseudomonas Aeruginosa; phosphate buffered saline (PBS)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valneva Austria GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne Eder, Mag

Role: STUDY_CHAIR

Valneva Austria GmbH

Locations

LKH - University Clinic Graz

Graz, Graz, Austria

LKH Salzburg

Salzburg, Salzburg, Austria

Medical University of Vienna

Vienna, Vienna, Austria

Otto Wagner Spital

Vienna, Vienna, Austria

Wilhelminenspital & Kaiserin-Elisabeth-Spital

Vienna, Vienna, Austria

Krankenhaus Hietzing

Vienna, , Austria

ULB Hospital Erasme

Brussels, Brussels Capital, Belgium

University Hospital Brussels

Brussels, Brussels Capital, Belgium

Hospital Saint Luc

Brussels, Brussels Capital, Belgium

Ziekenhuis Oost Limburg

Genk, Genk, Belgium

University Hospital Ghent

Ghent, Ghent, Belgium

Clinique St. Pierre

Ottignies, Ottignies, Belgium

Faculty Hospital St. Ann

Brno, Brno, Czechia

Faculty Hospital

Hradec Krakove, Hradec Krakove, Czechia

Faculty Hospital Kralovske Vinohrady

Prague, Prague, Czechia

Faculty Hospital Motol

Prague, Prague, Czechia

Central Military Hospital

Prague, Prague, Czechia

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Krajská nemocnice T. Bati, a.s.

Zlín, , Czechia

HELIOS Klinikum Aue

Aue, Aue, Germany

Carl-Thiem-Klinikum Cottbus

Cottbus, Cottbus, Germany

Städtisches Klinikum Dessau

Dessau, Dessau-Roßlau, Germany

Klinikum Dortmund

Dortmund, Dortmund, Germany

Neurologische Universitätsklinik

Dresden, Dresden, Germany

HELIOS Klinikum Erfurt

Erfurt, Erfurt, Germany

Helios Kreikrankenhaus Gotha/Ohrdruf

Gotha, Gotha, Germany

Bermannstrost BG Kliniken Halle

Halle, Halle/Saale, Germany

Saarland University Hospital

Homburg/Saar, Homburg/Saar, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Kiel, Germany

Klinikum rechts der Isar

München, München, Germany

HELIOS Klinikum Berlin-Buch

Berlin, State of Berlin, Germany

Charite-Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

HELIOS Klinikum Wuppertal

Wuppertal, Wuppertal, Germany

St. Imre Hospital

Budapest, Budapest, Hungary

Uzsoki Hospital

Budapest, Budapest, Hungary

Kenezy Korhaz Debrecen

Debrecen, Debrecen, Hungary

Debreceni Egyetem OEC Kazincbarcikai Korhaz

Kazincbarcika, Kazincbarcika, Hungary

Flor Ferenc Korhaz Hospital

Kistarcsa, Kistarcsa, Hungary

University of Pecs

Pécs, Pecs, Hungary

University of Szeged

Szeged, Szeged, Hungary

Fejer County Hospital

Székesfehérvár, Szekesfehervar, Hungary

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, , Hungary

Pécsi Tudományegyetem Neurológiai Klinika

Pécs, , Hungary

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Hospital Universitario de Getafe

Madrid, Madrid, Spain

University Hospital Marques de Valdecilla

Santander Cantabria, Santander Cantabria, Spain

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Hospital Universitario y Policlínico La Fe

Valencia, , Spain

Countries

Austria; Belgium; Czechia; Germany; Hungary; Spain

References

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.

Reference Type: DERIVED

PMID: 32131866 (View on PubMed)

Other Identifiers

IC43-202

Identifier Type: -

Identifier Source: org_study_id