Clinical trial NCT00876252: Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients
Official title: A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia, Ventilator-Associated
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
timeFrame: Day 14
Secondary outcomes:
measure: Immunogenicity at day 7
timeFrame: Day 7
measure: Rate of serious adverse events
timeFrame: Day 7
measure: Safety laboratory parameters
timeFrame: Day 7
measure: Systemic tolerability
timeFrame: Day 7
measure: Local tolerability
timeFrame: Day 7
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Valneva Austria GmbH
name: Nicole Haas
role: STUDY_DIRECTOR
References:
citation: 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.