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

Recruiting Phase 1 Interventional Study
Klebsiella Pneumoniae Infection Vaccine
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
40 (estimated)
Sponsor
Cho Pharma Inc. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 …
Contacts

Tanny Tsao

886226558059

tanny.tsao@chopharma.com.tw

CONTACT

Ming-Hung Tsai

886226558059

haircutter@chopharma.com.tw

CONTACT