Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00876252
First received: April 3, 2009
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pneumonia, Ventilator-Associated
Biological: IC43
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity at day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Rate of serious adverse events [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Safety laboratory parameters [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Systemic tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Local tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC43 100 mcg
IC43 100 mcg with Aluminum hydroxide
Biological: IC43
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 200 mcg
IC43 200 mcg with Aluminum hydroxide
Biological: IC43
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 100 mcg w/o
IC43 100 mcg without Aluminum hydroxide
Biological: IC43
Other Name: 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 Name: phosphate buffered saline (PBS)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876252

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Nicole Haas Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00876252     History of Changes
Other Study ID Numbers: IC43-201
Study First Received: April 3, 2009
Last Updated: October 18, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 29, 2014