Klebsiella Pneumoniae InfectionPhase 1NCT07016152
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
A Phase 1 study testing Glyconjugate Klebsiella pneumoniae bivalent vaccine in people with Klebsiella Pneumoniae Infection and Vaccine, run by Cho Pharma Inc. at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Klebsiella Pneumoniae Infection, Vaccine
- What is being tested?
- Glyconjugate Klebsiella pneumoniae bivalent vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jun 2025to 10 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- In generally good health by medical history, physical examination, vital signs, and clinical laboratory findings at the Screening visit based on the investigator's judgment.
- Negative serology test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
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- Female subject with childbearing potential must have a negative result of pregnancy test at the Screening visit.
- Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period.
- Male subject who agrees to use an adequate method of contraception during the study period.
Who cannot join
- 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.
- Medical conditions as a contraindication to the intramuscular vaccination and blood draws, e.g., coagulation disorder.
- Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (deltoid region).
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- Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal diseases and/or insufficiency as determined by physical examination or laboratory tests.
- Known or suspected impairment of immunological function, e.g., asplenia/splenectomy or history of autoimmune/immune-mediated diseases or lymphoproliferative disorders.
- Any screening laboratory abnormalities that are Grade 2 or above or deemed clinically significant in the opinion of the investigator.
- Subjects with an electrocardiogram (ECG) at the Screening visit that demonstrates clinically relevant abnormalities which may affect subject safety or study results in the opinion of the investigator.
- Positive test for SARS-CoV-2 virus at the Screening visit.
- Use of any antibiotic therapy within 1 week prior to the first study vaccination.
- History of any chronic or progressive disease that, according to judgment of the investigator, could interfere with the study outcomes or pose a threat to the subject's health.
- History of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.
- History or presence of heavy smoking (defined as > 10 cigarettes per day; approximately half pack per day) as documented in medical chart or by verbal confirmation at the Screening visit.
- Documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months prior to the Screening visit.
- Received any vaccination (live, inactivated, or bacterial) within 1 month prior to the Screening visit and plans to receive vaccination within 4 weeks after the last study vaccination during the study period. Exception can be made with marketed vaccines against seasonal influenza or COVID-19 outside the 28-day window of the study vaccination.
- Received major surgery or radiation therapy within 3 months prior to the Screening visit.
- Onset of influenza-like illness as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening visit.
- Female subject who is pregnant or lactating at the Screening visit or plans to be pregnant during the study period or lactate from the time of the first vaccination through 60 days after the last vaccination.
- Received any investigational drug or device or have participated in a clinical study within 3 months prior to the Screening visit.
- Any confirmed or suspected abnormal immune function, immunosuppression, or immunodeficiency or received any immunosuppressants (including systemic corticosteroids) or immunomodulators within 3 months prior to the Screening visit.
- Had blood donation within 2 weeks prior to the Screening visit.
- Received any blood products or immunoglobulin within 3 months prior to the Screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital- Clinical Trial Center
Taipei, 100025
National Taiwan University Hospital- Clinical Trial Center, 88623123456, tanny.tsao@chopharma.com.tw
About this study
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
- Klebsiella Pneumoniae Infection, Vaccine
- Being tested
- Glyconjugate Klebsiella pneumoniae bivalent vaccine
- Keywords
- Klebsiella Pneumoniae Infection, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyconjugate Klebsiella pneumoniae bivalent vaccineBiological
CHO-V08 is a glycoconjugate bivalent vaccine in sterile suspension.
| Study group | Role | What they receive |
|---|---|---|
| low dose (CHO-V08) | Experimental | Not described Receives: Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine |
| high dose (CHO-V08) | Experimental | Not described Receives: Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
To assess the immunogenicity of immunoglobulins M and G (IgM and IgG) following the CHO-V08 vaccination.
- Geometric mean titer (GMT) of Kp serotype specific IgM and IgG antibody titers.
- Seroconversion rate (SCR) in Kp serotype specific IgG antibody titers from baseline.
- The geometric mean fold rise (GMFR) in Kp serotype specific IgM and IgG antibody titers from baseline.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start26 Jun 2025
- Primary completion5 Nov 2026 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klebsiella Pneumoniae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cho Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016152
- Sponsor's protocol ID
- KLEBBI-001
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07016152
- Acronym / sponsor ID
- KLEBBI-001
- Conditions
- Klebsiella Pneumoniae Infection, Vaccine
- Keywords
- Klebsiella Pneumoniae Infection, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cho Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose (CHO-V08) | Experimental | Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine |
| high dose (CHO-V08) | Experimental | Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- In generally good health by medical history, physical examination, vital signs, and clinical laboratory findings at the Screening visit based on the investigator's judgment.
Key exclusion criteria (24 listed)
- 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.
- Medical conditions as a contraindication to the intramuscular vaccination and blood draws, e.g., coagulation disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyconjugate Klebsiella pneumoniae bivalent vaccineCHO-V08 is a glycoconjugate bivalent vaccine in sterile suspension. | Biological | high dose (CHO-V08), low dose (CHO-V08) |
Primary outcome
To evaluate the safety and reactogenicity of the CHO-V08 vaccination.
Time frame: 1 year
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.
1 secondary outcome
To assess the immunogenicity of immunoglobulins M and G (IgM and IgG) following the CHO-V08 vaccination.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glyconjugate Klebsiella pneumoniae bivalent vaccine in people with Klebsiella Pneumoniae Infection and Vaccine, run by Cho Pharma Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanny Tsao (886226558059, tanny.tsao@chopharma.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and reactogenicity of the CHO-V08 vaccination. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.