Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876252
• Other study ID #: IC43-201
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2009
• Last updated: October 18, 2012
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2012
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated

Intervention

Biological:
• IC43

Drug:
• Placebo
NaCl

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo		Day 14	Yes
Secondary	Immunogenicity at day 7		Day 7	Yes
Secondary	Rate of serious adverse events		Day 7	Yes
Secondary	Safety laboratory parameters		Day 7	Yes
Secondary	Systemic tolerability		Day 7	Yes
Secondary	Local tolerability		Day 7	Yes