Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers

Against Pseudomonas Aeruginosa in Healthy Volunteers

The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: IC43; Drug: Placebo

Detailed Description

The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Univ.-Prof. Dr. Bernd Jilma
• Germany
  • Göttingen, Germany
    • Dr. Daniel Sehrt
  • Münster, Germany
    • Dr. Jutta Harten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• written informed consent obtained prior to study entry
• healthy adults aged between 18 and 65 years
• no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
• In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception

Exclusion Criteria:

• History of autoimmune diseases and malignancies
• Active or passive vaccination 4 weeks before and during the entire study protocol
• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
• History of severe hypersensitivity reactions and anaphylaxis
• Known hypersensitivity or allergic reactions to one of the components of the vaccine
• Clinically significant diseases as judged by the investigator
• Immunodeficiency due to immunosuppressive therapy
• A family history of congenital or hereditary immunodeficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IC43 50; IC43 50 mcg with AI(OH)3	Biological: IC43; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; Other Names: IC43 Pseudomonas Aeruginosa
ACTIVE_COMPARATOR: IC43 100 with; IC43 100 mcg with AI(OH)3	Biological: IC43; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; Other Names: IC43 Pseudomonas Aeruginosa
ACTIVE_COMPARATOR: IC43 100 w/o; IC43 100 mcg w/o AI(OH)3	Biological: IC43; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; Other Names: IC43 Pseudomonas Aeruginosa
ACTIVE_COMPARATOR: IC43 200; IC43 200 mcg with AI(OH)3	Biological: IC43; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; Other Names: IC43 Pseudomonas Aeruginosa
PLACEBO_COMPARATOR: Placebo; Placebo (0,9% NaCl)	Drug: Placebo; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; Other Names: NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
immunogenicity at day 14	see above
rate of serious adverse events during vaccination period until 6 months after first vaccination	see above
safety laboratory parameters at intervals up to day 180	see above
systemic and local tolerability at intervals up to day 180	see above

Secondary Outcome Measures

Outcome Measure	Time Frame
immunogenicity	see above
measurement of functional antibody induction	see above
measurement of antibody avidity on days 7 and 14	see above
measurement of anti-histidine antibodies on days 7, 14, 90, and 180	see above

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH
• Investigators: Study Director: Sonja Ernsthofer, Mag., Valneva Austria GmbH

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 22, 2008
• First Posted (ESTIMATE): October 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Pseudomonas Aeruginosa
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pseudomonas Infections
• Other Study ID Numbers: IC43-101