An Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of a Bivalent Klebsiella Pneumoniae Vaccine (CHO-V08) in Healthy Adults

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCho Pharma Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Glyconjugate Klebsiella pneumoniae bivalent vaccine

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators