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Staphylococcus aureus vaccination before heart surgery fails to deliver

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2200 (Published 10 April 2013) Cite this as: BMJ 2013;346:f2200

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Merck’s V710 vaccine, developed to prevent infection with Staphylococcus aureus after heart surgery, failed to deliver. A trial done across 26 countries with more than 7000 participants was stopped early after a second preplanned interim analysis suggested the vaccine was ineffective and harmful.

Despite a good antibody response to the vaccine, it was no more effective than placebo in preventing the primary outcome—S aureus bacteraemia or deep sternal wound infection (including mediastinitis), or both, up to postoperative day 90. This outcome was seen in 22 of 3528 patients randomised to the vaccine (2.6/100 person years) versus 27 of 3517 given placebo (3.2/100 person years); relative risk 0.81, 95% CI 0.44 to 1.48. No effect was seen on secondary outcomes either, which included all S aureus surgical site and invasive infections to day 90.

Adverse events were more common with the vaccine (30.8% v 21.8% with placebo), as were serious adverse events (1.7% v 1.3%); 31 multiorgan failure events were seen with the vaccine versus 17 with placebo (0.9 v 0.5 per 100 person years; P=0.04).

All cause mortality was similar in the two groups (5.7% v 5.0%), but people who developed staphylococcal infections after receiving the vaccine were more likely to die than those who received placebo (15/73 v 4/96; difference 18.8/100 person years).

Notes

Cite this as: BMJ 2013;346:f2200