CHO-V08 is currently being developed as a prevention vaccine against nosocomial and community-acquired infection caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. The goal of study (KLEBBI-001) is to evaluate the safety, reactogenicity, and immunogenicity of the preventive vaccine of CHO-V08 in healthy volunteers aged from 18 to 50 years old.
Male or non-pregnant female, aged 18 to 50 years old (inclusive) for Cohorts 1 and 2 at the Screening visit.
Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at the Screening visit.
Physically and mentally capable of participating in the study and willing to adhere to study procedures.
Able to provide signed informed consent.
Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of AEs.
Suspected or known hypersensitivity (including allergy) to any of the vaccine components.
History of hypersensitivity or allergy to any vaccine, especially pneumococcal vaccine.
Current or previous, confirmed, or suspected disease caused by Klebsiella pneumoniae.
Sequential
Glyconjugate Klebsiella pneumoniae bivalent vaccine
Biological/VaccineCHO-V08 is a glycoconjugate bivalent vaccine in sterile suspension.
To evaluate the safety and reactogenicity of the CHO-V08 vaccination.
Occurrence, severity, and relationship of immediate adverse reactions, solicited, unsolicited adverse events following each vaccination. Occurrence, severity, and relationship of medically-attended AEs (MAAEs), adverse events of special interest (AESIs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs) through the study completion.
To assess the immunogenicity of immunoglobulins M and G (IgM and IgG) following the CHO-V08 vaccination.
1. Geometric mean titer (GMT) of Kp serotype specific IgM and IgG antibody titers. 2. Seroconversion rate (SCR) in Kp serotype specific IgG antibody titers from baseline. 3. The geometric mean fold rise (GMFR) in Kp serotype specific IgM and IgG antibody titers from baseline.
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