The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
157
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.
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.
Univ.-Prof. Dr. Bernd Jilma
Vienna, State of Vienna, Austria
Dr. Daniel Sehrt
Göttingen, Göttingen, Germany
Dr. Jutta Harten
Münster, Münster, Germany
immunogenicity at day 14
Time frame: see above
rate of serious adverse events during vaccination period until 6 months after first vaccination
Time frame: see above
safety laboratory parameters at intervals up to day 180
Time frame: see above
systemic and local tolerability at intervals up to day 180
Time frame: see above
immunogenicity
Time frame: see above
measurement of functional antibody induction
Time frame: see above
measurement of antibody avidity on days 7 and 14
Time frame: see above
measurement of anti-histidine antibodies on days 7, 14, 90, and 180
Time frame: see above
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