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

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

Detailed Description
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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.

Official Title
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Against Pseudomonas Aeruginosa in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: IC43
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC43 50<br>IC43 50 mcg with AI(OH)3 | Biological: IC43<br>* 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.<br>* Other names: IC43 Pseudomonas Aeruginosa;|
| Active Comparator: IC43 100 with<br>IC43 100 mcg with AI(OH)3 | Biological: IC43<br>* 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.<br>* Other names: IC43 Pseudomonas Aeruginosa;|
| Active Comparator: IC43 100 w/o<br>IC43 100 mcg w/o AI(OH)3 | Biological: IC43<br>* 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.<br>* Other names: IC43 Pseudomonas Aeruginosa;|
| Active Comparator: IC43 200<br>IC43 200 mcg with AI(OH)3 | Biological: IC43<br>* 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.<br>* Other names: IC43 Pseudomonas Aeruginosa;|
| Placebo Comparator: Placebo<br>Placebo (0,9% NaCl) | Drug: Placebo<br>* 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.<br>* Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudomonas Aeruginosa