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Tests treatment safety and results for Klebsiella Pneumoniae Infection
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
What this study is testing
What is Glyconjugate Klebsiella pneumoniae bivalent vaccine?
Glyconjugate Klebsiella pneumoniae bivalent vaccine is an investigational medicine, being studied as a potential treatment for klebsiella pneumoniae infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join if
- Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the...
- 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...
See the full eligibility 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 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.
- 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.
- people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.