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

Pseudomonas Aeruginosa Infection Clinical Trial

Official title:

A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01563263
• Other study ID #: IC43-202
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: March 14, 2012
• Last updated: September 25, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: EthikkommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionBelgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsHungary: Institutional Ethics CommitteeHungary: Ministry of Health, Social and Family AffairsSpain: Ethics CommitteeSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pseudomonas Aeruginosa Infection
• Pseudomonas Infections

Intervention

Biological:
• IC43
100 mcg

Drug:
• Placebo
phosphate buffered saline (PBS) solution containing 0,9 % NaCl

Locations

Country	Name	City	State
Austria	LKH - University Clinic Graz	Graz
Austria	LKH Salzburg	Salzburg
Austria	Krankenhaus Hietzing	Vienna
Austria	Medical University of Vienna	Vienna
Austria	Otto Wagner Spital	Vienna
Austria	Wilhelminenspital & Kaiserin-Elisabeth-Spital	Vienna
Belgium	Hospital Saint Luc	Brussels
Belgium	ULB Hospital Erasme	Brussels
Belgium	University Hospital Brussels	Brussels
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	University Hospital Ghent	Ghent
Belgium	Clinique St. Pierre	Ottignies
Czech Republic	Faculty Hospital St. Ann	Brno
Czech Republic	Faculty Hospital	Hradec Krakove
Czech Republic	Fakultní nemocnice Olomouc	Olomouc
Czech Republic	Faculty Hospital Kralovske Vinohrady	Prague
Czech Republic	Faculty Hospital Motol	Prague
Czech Republic	Central Military Hospital	Praha
Czech Republic	Krajská nemocnice T. Bati, a.s.	Zlín
Germany	HELIOS Klinikum Aue	Aue
Germany	Charite-Universitätsmedizin Berlin	Berlin
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Carl-Thiem-Klinikum Cottbus	Cottbus
Germany	Städtisches Klinikum Dessau	Dessau-Roßlau
Germany	Klinikum Dortmund	Dortmund
Germany	Neurologische Universitätsklinik	Dresden
Germany	HELIOS Klinikum Erfurt	Erfurt
Germany	Helios Kreikrankenhaus Gotha/Ohrdruf	Gotha
Germany	Bermannstrost BG Kliniken Halle	Halle/Saale
Germany	Saarland University Hospital	Homburg/Saar
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Klinikum rechts der Isar	München
Germany	HELIOS Klinikum Wuppertal	Wuppertal
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	St. Imre Hospital	Budapest
Hungary	Uzsoki Hospital	Budapest
Hungary	Kenezy Korhaz Debrecen	Debrecen
Hungary	Debreceni Egyetem OEC Kazincbarcikai Korhaz	Kazincbarcika
Hungary	Flor Ferenc Korhaz Hospital	Kistarcsa
Hungary	University of Pecs	Pecs
Hungary	Pécsi Tudományegyetem Neurológiai Klinika	Pécs
Hungary	University of Szeged	Szeged
Hungary	Fejer County Hospital	Szekesfehervar
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de Getafe	Madrid
Spain	University Hospital Marques de Valdecilla	Santander Cantabria
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	Hospital Universitario y Policlínico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Germany,  Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of deaths until Day 28		until Day 28	Yes
Secondary	number of deaths in comparison on Day 14, 56 and 90		until Day 90	No
Secondary	number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo		until Day 90	No
Secondary	number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo		until Day 90	No
Secondary	number of overall survival in all patients and in patients surviving Day 14		until Day 180	No
Secondary	number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo		until Day 90	No
Secondary	number of surviving subjects after Sepsis receiving IC43 or placebo		until Day 180	No
Secondary	number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180		until Day 180	No
Secondary	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	No
Secondary	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	No
Secondary	Organ function in patients receiving IC43 or placebo during ICU stay		during ICU stay	No
Secondary	Days of ICU stay in patients receiving IC43 or placebo		Until Day 180	No
Secondary	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	No
Secondary	Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination		until Day 180	Yes
Secondary	systemic tolerability	blood pressure	until Day 7	Yes
Secondary	number of local reactions at the injection site		until Day 180	Yes
Secondary	Composite measure of laboratory parameters		until Day 56	Yes
Secondary	systemic tolerability	pulse	until Day 7	Yes
Secondary	systemic tolerability	body temperature	until Day 7	Yes