Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Phase 2

Completed

• Conditions: Pneumonia, Ventilator-Associated
• Interventions: Biological: IC43; Drug: Placebo

• Registration Number: NCT00876252
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

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.

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC43 100 mcg	IC43	IC43 100 mcg with Aluminum hydroxide
IC43 200 mcg	IC43	IC43 200 mcg with Aluminum hydroxide
IC43 100 mcg w/o	IC43	IC43 100 mcg without Aluminum hydroxide
Placebo	Placebo	phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of serious adverse events	Day 7
Safety laboratory parameters	Day 7
Immunogenicity at day 7	Day 7
Systemic tolerability	Day 7
Local tolerability	Day 7

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria