Phase 1 Study to Evaluate Safety and Immune Response of CHO-V08 Bivalent Klebsiella Pneumoniae Vaccine in Healthy Adults Aged 18 to 50

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.

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