The safety and immunogenicity of a recombinant five-antigen Staphylococcus aureus vaccine among patients undergoing elective surgery for closed fractures: A randomized, double-blind, placebo-controlled, multicenter phase 2 clinical trial.

BACKGROUND: Vaccines are urgently required to control Staphylococcus aureus hospital and community infections and reduce the use of antibiotics. Here, we report the safety and immunogenicity of a recombinant five-antigen Staphylococcus aureus vaccine (rFSAV) in patients undergoing elective surgery for closed fractures. METHODS: A randomized, double-blind, placebo-controlled, multicenter phase 2 clinical trial was carried out in 10 clinical research centers in China. Patients undergoing elective surgery for closed fractures, aged 18-70 years, were randomly allocated at a ratio of 1:1 to receive the rFSAV or placebo at a regimen of two doses on day 0 and another dose on day 7. All participants and investigators remained blinded during the study period. The safety endpoint was the incidence of adverse events within 180 days. The immunogenicity endpoints included the level of specific antibodies to five antigens after vaccination, as well as opsonophagocytic antibodies. RESULTS: A total of 348 eligible participants were randomized to the rFSAV (n = 174) and placebo (n = 174) groups. No grade 3 local adverse events occurred. There was no significant difference in the incidence of overall systemic adverse events between the experimental (40.24 %) and control groups (33.72 %) within 180 days after the first immunization. The antigen-specific binding antibodies started to increase at days 7 and reached their peaks at 10-14 days after the first immunization. The rapid and potent opsonophagocytic antibodies were also substantially above the background levels. CONCLUSIONS: rFSAV is safe and well-tolerated in patients undergoing elective surgery for closed fractures. It elicited rapid and robust specific humoral immune responses using the perioperative immunization procedure. These results provide evidence for further clinical trials to confirm the vaccine efficacy. China's Drug Clinical Trials Registration and Information Publicity Platform registration number: CTR20181788. WHO International Clinical Trial Registry Platform identifier: ChiCTR2200066259.

Preparation of Polytetrafluoroethylene Superhydrophobic Materials by Femtosecond Laser Processing Technology.

In recent years, superhydrophobic surfaces have attracted significant attention due to their promising applications, especially in ice prevention, reduction in air resistance, and self-cleaning. This study utilizes femtosecond laser processing technology to prepare different surface microstructures on polytetrafluoroethylene (PTFE) surfaces. Through experiments, it investigates the relationship between the solid-liquid contact ratio and surface hydrophobicity. The shape of water droplets on different microstructure surfaces is simulated using ANSYS, and the relationship between surface microstructures and hydrophobicity is explored in the theoretical model. A superhydrophobic surface with a contact angle of up to 166° was obtained by machining grooves with different spacings in polytetrafluoroethylene sheets with femtosecond laser technology. Due to the micro- and nanostructures on the surface, the oleophobicity of the processed oleophilic PTFE surface is enhanced.