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

•rFSAV is a novel recombinant five-antigen Staphylococcus aureus vaccine.•rFSAV was assessed in patients undergoing elective surgery for closed fractures for the first time.•rFSAV is safe, well tolerated in patients undergoing elective surgery for closed fractures.•rFSAV elicits rapid and robust specific humoral immune responses in targeted population.•rFSAV is worth further evaluation in in phase 3 studies in a larger number of individuals.