(HealthDay News) – A vaccine against Staphylococcus aureus is ineffective in preventing post-operative S. aureus infection and has serious safety problems when given pre-operatively to patients undergoing cardiothoracic surgery, according to a study published online April 2 in the Journal of the American Medical Association.
Vance G. Fowler Jr., MD, MHS, from Duke University Medical Center in Durham, NC, and colleagues randomly assigned 8,031 adult patients to a single injection with placebo or V710 vaccine against Staphylococcus aureus 14–60 days before undergoing full median sternotomy.
The researchers found that although the V710 vaccine elicited a robust antibody response, at 90 days post-surgery, it was no more effective than placebo in preventing S aureus bacteremia and/or deep sternal wound infection or in preventing all S aureus surgical site and invasive infections. The V710 vaccine was also associated with more adverse experiences during the 14 days after vaccination (injection site reactions and serious adverse events) and a significantly higher rate of multi-organ failure during the entire study. Among patients with staphylococcal infections, the mortality rate was significantly higher for patients who had received the V710 vaccine. The study was terminated early due to safety concerns and low efficacy.
“Among patients undergoing cardiothoracic surgery with median sternotomy, the use of a vaccine against S aureus compared with placebo did not reduce the rate of serious post-operative S aureus infections and was associated with increased mortality among patients who developed S aureus infections,” the authors write.
The study was funded by Merck Sharp & Dohme. Several authors are employees of Merck, and numerous authors reported financial relationships with Merck and other pharmaceutical and biotechnology companies.