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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Parexel International GmbH, Institute for Clinical Pharmacology
Berlin, State of Berlin, Germany
Occurrence of any SAEs (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
Time frame: Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
Time frame: Day 0 - Day 264
Determination of vaccine-specific IgG levels
Time frame: Day 0 - Day 264
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