drugset / Trial / NCT04959344
Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)
RandomizedParallel-groupTriple-blindPrevention
Summary
In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.
Timeline
- Start
- 2021-07-05
- Primary completion
- 2022-09-26
- Completion
- 2022-09-26
Publications
- Alaimo C, Karaky N, Lawrence R, Bownes E, Haffner S, Kowarik M, Goldblatt D, Martin P. Safety and Immunogenicity of a Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Administered to Healthy Adults: A First-in-Human Phase I/II Randomized and Controlled Study. J Infect Dis. 2026 Feb 18;233(2):e342-e351. doi: 10.1093/infdis/jiaf600.
- Chen Z, Gou Q, Yuan Y, Zhang X, Zhao Z, Liao J, Zeng X, Jing H, Jiang S, Zhang W, Zeng H, Huang W, Zou Q, Zhang J. Vaccination with a trivalent Klebsiella pneumoniae vaccine confers protection in a murine model of pneumonia. Vaccine. 2024 Oct 3;42(23):126217. doi: 10.1016/j.vaccine.2024.126217. Epub 2024 Aug 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AS03 | Other / unclassified | — | — |
| Subject | Kleb4V | Unknown | 16 ug | Intramuscular |
| Subject | Kleb4V | Unknown | 64 ug | Intramuscular |