Actively Recruiting
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
Led by Cho Pharma Inc. · Updated on 2025-06-27
40
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 50 years inclusive at screening
- Body mass index between 18.0 and 30.0 kg/m2 inclusive at screening
- Physically and mentally able to participate and willing to follow study procedures
- Able to provide signed informed consent
- Generally healthy based on medical history, physical exam, vital signs, and lab results at screening
- Negative tests for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody at screening
- Female of childbearing potential with negative pregnancy test at screening
- Female of childbearing potential willing to use highly effective contraception during study
- Male agreeing to use adequate contraception during study
You will not qualify if you...
- Any medical or psychiatric condition that could interfere with participation or increase risk
- Known or suspected allergy to vaccine components or history of allergy to any vaccine, especially pneumococcal vaccine
- Current or past confirmed or suspected Klebsiella pneumoniae infection
- Medical contraindications to intramuscular vaccination or blood draws, e.g., coagulation disorder
- Body abnormalities or permanent tattoos that interfere with injection site observation
- Significant acute or chronic cardiovascular, lung, liver, or kidney disease
- Known or suspected immune system impairment or history of autoimmune or lymphoproliferative disorders
- Lab abnormalities Grade 2 or higher or clinically significant per investigator
- Abnormal ECG at screening that affects safety or study results
- Positive test for SARS-CoV-2 at screening
- Use of antibiotics within 1 week before first vaccination
- History of chronic or progressive disease affecting study outcomes or health
- Cancer history within 5 years except localized skin cancer without metastases
- Heavy smoking history (>10 cigarettes/day) documented or reported
- Substance or alcohol abuse within 6 months prior to screening
- Vaccination within 1 month before screening or planned vaccination within 4 weeks after last study vaccination, except seasonal flu or COVID-19 vaccines outside study window
- Major surgery or radiation therapy within 3 months prior to screening
- Influenza-like illness within 1 week prior to screening
- Female pregnant, lactating, or planning pregnancy during study or within 60 days after last vaccination
- Participation in other clinical studies or investigational drug/device use within 3 months prior to screening
- Confirmed or suspected immunosuppression or immunodeficiency or use of immunosuppressants/immunomodulators within 3 months prior to screening
- Blood donation within 2 weeks prior to screening
- Receipt of blood products or immunoglobulin within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital- Clinical Trial Center
Taipei, Taiwan, 100025
Actively Recruiting
Research Team
T
Tanny Tsao
CONTACT
M
Ming-Hung Tsai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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