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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: IC43; Drug: Placebo

• Registration Number: NCT00778388
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

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

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC43 50	IC43	IC43 50 mcg with AI(OH)3
IC43 100 with	IC43	IC43 100 mcg with AI(OH)3
IC43 200	IC43	IC43 200 mcg with AI(OH)3
IC43 100 w/o	IC43	IC43 100 mcg w/o AI(OH)3
Placebo	Placebo	Placebo (0,9% NaCl)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Dr. Jutta Harten; 🇩🇪 Münster, Germany

Univ.-Prof. Dr. Bernd Jilma; 🇦🇹 Vienna, Austria

Dr. Daniel Sehrt; 🇩🇪 Göttingen, Germany