Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47

Study Overview
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Brief Summary
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The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination. A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.

Detailed Description
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This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Official Title
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An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: IC47


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Healthy adults ≥ 18 to </= 65 female subjects: post-menopausal or practicing reliable methods of contraception during the study Exclusion Criteria: History of autoimmune diseases and malignancies. History of severe hypersensitivity reactions and anaphylaxis. Immunodeficiency due to immunosuppressive therapy. Infection with HIV, Hepatitis B or Hepatitis C. Pregnancy, lactation Vulnerable subjects

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC47 30 mcg<br>30 mcg with Alum | Biological: IC47<br>* solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84<br>|
| Experimental: IC47 30 mcg w/o<br>30 mcg without Alum | Biological: IC47<br>* solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84<br>|
| Experimental: IC47 150 mcg<br>150 mcg with Alum | Biological: IC47<br>* solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84<br>|
| Experimental: IC47 150 mcg w/o<br>150 mcg without Alum | Biological: IC47<br>* solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any SAEs (possibly)related to the study vaccine |  | Day 0 - Day 264 | 
| Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine |  | Day 0 - Day 264 | 
| Occurrence of solicited local and systemic AEs within 1 week after vaccination |  | Day 0 - Day 264 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of vaccine-specific IgG levels |  | Day 0 - Day 264 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of pneumococcal infections