The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach, Germany
Number of subjects with serious and non serious adverse events
Time frame: Up to 12 months
Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.
Time frame: Up to day 49
MTD of CV8102 in combination with rabies vaccine
Time frame: Up to Day 49
Vaccination-elicited serum rabies VNTs among the dose groups
Time frame: Up to day 35
Vaccination-elicited innate and adaptive immune responses
Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)
Time frame: Up to Day 35
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