A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

Summary

This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.

Timeline

Start

2019-05-16

Primary completion

2019-12-16

Completion

2020-05-16

Publications

• Zhu FC, Zeng H, Li JX, Wang B, Meng FY, Yang F, Gu J, Liang HY, Hu YM, Liu P, Peng LS, Hu XK, Zhuang Y, Fan M, Li HB, Tan ZM, Luo P, Zhang P, Chu K, Zhang JY, Zeng M, Zou QM. Evaluation of a recombinant five-antigen Staphylococcus aureus vaccine: The randomized, single-centre phase 1a/1b clinical trials. Vaccine. 2022 May 20;40(23):3216-3227. doi: 10.1016/j.vaccine.2022.04.034. Epub 2022 Apr 23.
• Wei J, Cheng X, Zhang Y, Gao C, Wang Y, Peng Q, Luo P, Yang L, Zou Q, Zeng H, Gu J. Identification and application of a neutralizing epitope within alpha-hemolysin using human serum antibodies elicited by vaccination. Mol Immunol. 2021 Jul;135:45-52. doi: 10.1016/j.molimm.2021.03.028. Epub 2021 Apr 16.

Drugs

Indications