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Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Primary Purpose

Pneumonia, Ventilator-Associated

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

IC43

Placebo

About this trial

This is an interventional treatment trial for Pneumonia, Ventilator-Associated

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IC43 100 mcg

IC43 200 mcg

IC43 100 mcg w/o

Placebo

Arm Description

IC43 100 mcg with Aluminum hydroxide

IC43 200 mcg with Aluminum hydroxide

IC43 100 mcg without Aluminum hydroxide

phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant

Outcomes

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

Secondary Outcome Measures

Immunogenicity at day 7

Rate of serious adverse events

Safety laboratory parameters

Systemic tolerability

Local tolerability

Full Information

NCT ID

NCT00876252

First Posted

April 3, 2009

Last Updated

October 18, 2012

Sponsor

Valneva Austria GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00876252

Brief Title

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valneva Austria GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Ventilator-Associated

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IC43 100 mcg

Arm Type

Active Comparator

Arm Description

IC43 100 mcg with Aluminum hydroxide

Arm Title

IC43 200 mcg

Arm Type

Active Comparator

Arm Description

IC43 200 mcg with Aluminum hydroxide

Arm Title

IC43 100 mcg w/o

Arm Type

Active Comparator

Arm Description

IC43 100 mcg without Aluminum hydroxide

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant

Intervention Type

Biological

Intervention Name(s)

IC43

Other Intervention Name(s)

IC43 Pseudomonas Aeruginosa

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

phosphate buffered saline (PBS)

Intervention Description

NaCl

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Immunogenicity at day 7

Time Frame

Day 7

Title

Rate of serious adverse events

Time Frame

Day 7

Title

Safety laboratory parameters

Time Frame

Day 7

Title

Systemic tolerability

Time Frame

Day 7

Title

Local tolerability

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicole Haas

Organizational Affiliation

Valneva Austria GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

28159015

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.

Results Reference

derived

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Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

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