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

NCT07016152 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KLEBBI-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Klebsiella Pneumoniae Infection; Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• To assess the immunogenicity of immunoglobulins M and G (IgM and IgG) following the CHO-V08 vaccination.

  1 year

Study Arms (2)

low dose (CHO-V08)

EXPERIMENTAL

Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine

high dose (CHO-V08)

EXPERIMENTAL

Biological: Glyconjugate Klebsiella pneumoniae bivalent vaccine

Interventions

Glyconjugate Klebsiella pneumoniae bivalent vaccine BIOLOGICAL

CHO-V08 is a glycoconjugate bivalent vaccine in sterile suspension.

high dose (CHO-V08); low dose (CHO-V08)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Cho Pharma Inc.: lead

Study Sites (1)

National Taiwan University Hospital- Clinical Trial Center

Taipei, 100025, Taiwan

RECRUITING

Central Study Contacts

Tanny Tsao

CONTACT

886226558059; tanny.tsao@chopharma.com.tw

Ming-Hung Tsai

CONTACT

886226558059; haircutter@chopharma.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 11, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): April 10, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)