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
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CHO-V08, a bivalent vaccine designed to prevent infections caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. This Phase I study focuses on assessing the safety, reactogenicity, and immune response of the vaccine in healthy adults aged 18 to 50 years. The vaccine is being developed to reduce risks of both hospital-acquired and community-acquired Klebsiella pneumoniae infections. The study involves two experimental groups receiving different doses of the CHO-V08 glycoconjugate vaccine. Participants will be given the vaccine via injection, and the study is open-label and non-randomized, meaning both researchers and participants know the treatment given. The trial will monitor participants over one year to evaluate safety and immune response outcomes. During the study, participants will undergo health assessments including physical exams, vital signs monitoring, and laboratory tests such as blood draws and serology for infections. Researchers will track any side effects and measure immunoglobulin levels to understand vaccine response. Participants must adhere to study procedures and contraception requirements if applicable. The total participation duration will be about one year, with ongoing safety and immunogenicity evaluations.
CONDITIONS
Brief 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 old
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- Physically and mentally able to participate and follow study procedures
- Able to provide signed informed consent
- Generally healthy based on medical history, physical exam, vital signs, and lab tests
- Negative tests for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody
- Female participants with childbearing potential must have a negative pregnancy test
- Female participants with childbearing potential must agree to use effective contraception during the study
- Male participants must agree to use contraception during the study
You will not qualify if you...
- Any medical or psychiatric condition that may interfere with study participation or increase risk
- Known or suspected allergy to vaccine components or pneumococcal vaccine
- History or current disease caused by Klebsiella pneumoniae
- Medical conditions contraindicating intramuscular vaccination or blood draws, such as coagulation disorders
- Body abnormalities or tattoos at injection site that interfere with reaction observation
- Significant acute or chronic cardiovascular, pulmonary, liver, or kidney diseases
- Known or suspected immune system impairment or autoimmune diseases
- Clinically significant lab abnormalities or ECG findings at screening
- Positive test for SARS-CoV-2 virus
- Antibiotic use within 1 week before first vaccination
- History of chronic or progressive diseases that could affect study outcomes or health
- History of cancer (except localized skin cancer) within 5 years
- Heavy smoking history (more than 10 cigarettes per day)
- Substance or alcohol abuse within 6 months before screening
- Recent vaccinations within 1 month before screening or planned vaccinations within 4 weeks after last study vaccine (except seasonal flu or COVID-19 vaccines outside 28-day window)
- Major surgery or radiation therapy within 3 months before screening
- Flu-like illness within 1 week before screening
- Pregnancy or lactation during study period
- Participation in other clinical studies or investigational treatments within 3 months before screening
- Use of immunosuppressants or immunomodulators within 3 months before screening
- Blood donation within 2 weeks before screening
- Receipt of blood products or immunoglobulin within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive the CHO-V08 bivalent Klebsiella pneumoniae vaccine to evaluate its safety and immunogenicity.
Multiple visits for vaccination and immunogenicity assessments
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital- Clinical Trial Center
Taipei, Taiwan, 100025
Actively Recruiting
Research Team
T
Tanny Tsao
M
Ming-Hung Tsai
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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