Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Ventilator-Associated
• Intervention / Treatment: Biological: IC43; Drug: Placebo

Detailed Description

This is a randomized, placebo-controlled, multi-center, partially blinded [i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non-adjuvanted IC43 [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients aged between 18 and 80 years
• Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
• At high risk for acquiring infection against P. aeruginosa at visit 0.
• Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
• In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
• Written informed consent or waiver according to the national regulations

Exclusion Criteria:

• Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
• Low severity of illness defined by an acute physiology score < 8 at visit 0
• Patients < 6 months post organ transplantation
• Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
• Pregnancy, lactation
• Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IC43 100 mcg; IC43 100 mcg with Aluminum hydroxide	Biological: IC43; Other Names: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 200 mcg; IC43 200 mcg with Aluminum hydroxide	Biological: IC43; Other Names: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 100 mcg w/o; IC43 100 mcg without Aluminum hydroxide	Biological: IC43; Other Names: IC43 Pseudomonas Aeruginosa
Placebo Comparator: Placebo; phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant	Drug: Placebo; NaCl; Other Names: phosphate buffered saline (PBS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo	Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity at day 7	Day 7
Rate of serious adverse events	Day 7
Safety laboratory parameters	Day 7
Systemic tolerability	Day 7
Local tolerability	Day 7

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH
• Investigators: Study Director: Nicole Haas, Valneva Austria GmbH

Publications and helpful links

General Publications

• Rello J, Krenn CG, Locker G, Pilger E, Madl C, Balica L, Dugernier T, Laterre PF, Spapen H, Depuydt P, Vincent JL, Bogar L, Szabo Z, Volgyes B, Manez R, Cakar N, Ramazanoglu A, Topeli A, Mastruzzo MA, Jasovich A, Remolif CG, Del Carmen Soria L, Andresen Hernandez MA, Ruiz Balart C, Kremer I, Molnar Z, von Sonnenburg F, Lyons A, Joannidis M, Burgmann H, Welte T, Klingler A, Hochreiter R, Westritschnig K. A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients. Crit Care. 2017 Feb 4;21(1):22. doi: 10.1186/s13054-017-1601-9.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (Estimate): April 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: IC43-201