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The study included more than 7,000 thousand adult cardiothoracic patients. About half of them received an injection of the "V710" vaccine 14 to 60 days before their surgery, while the others received a placebo.
At 90 days after surgery, Staphylococcus aureus infections showed up in 22 of 3,528 vaccinated patients and in 27 of 3,517 patients who received the placebo. No significant differences in effectiveness were ever seen between the vaccine and placebo groups during the study.
The researchers also found that patients who received the vaccine had more negative side effects in the 14 days after vaccination than those who received the placebo (31 percent vs. 22 percent), including serious problems (1.7 percent vs. 1.3 percent).
In addition, patients who received the vaccine were much more likely to suffer multi-organ failure at some point in the study (31 vs. 17 events), according to the study in the April 3 issue of the Journal of the American Medical Association.
The difference in the death rate from all causes was not statistically significant between the groups of patients (201 of 3,958 vs. 177 of 3,967), but the death rate among patients who developed staph infections was much higher among those who received the vaccine (15 of 73 vs. 4 of 96), according to a journal news release.
"These findings do not support the use of the V710 vaccine for patients undergoing surgical interventions," concluded Dr. Vance Fowler Jr., of Duke University Medical Center, and colleagues.
Dr. Preeti Malani, of the University of Michigan Health System, wrote an accompanying journal editorial.
"While the prevention of S. aureus infections should remain a priority for future investigation, novel approaches must move beyond vaccine strategies -- and for that matter, beyond S. aureus. Even if a viable staphylococcal vaccine were to be developed, this would not address non-S. aureus infections," Malani wrote.
-- Robert Preidt
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