VACCINE

Human Vaccines And Immunotherapeutics • 2014
Mortality among recipients
of the Merck V710 Staphylococcus aureus vaccine
after postoperative S. aureus infections:
an analysis of possible contributing host factors
Author information
McNeely TB1, Shah NA, Fridman A, Joshi A,
Hartzel JS, Keshari RS, Lupu F, DiNubile MJ.
Merck Research Laboratories, West Point, PA USA
Abstract
In a blinded randomized trial, preoperative receipt of the Merck V710 Staphylococcus
aureus vaccine was associated with a higher mortality rate than placebo
in patients who later developed postoperative S. aureus infections. Of the
tested patients, all 12 V710 recipients (but only 1 of 13 placebo recipients) with
undetectable serum IL2 levels prior to vaccination and surgery died after postoperative
S. aureus infection. The coincidence of 3 factors (low prevaccination
IL-2 levels, receipt of V710, and postoperative S. aureus infection) appeared to
substantially increase mortality in our study population after major cardiothoracic
surgery. Furthermore, 9 of the 10 V710 recipients with undetectable preoperative
IL17a levels and postoperative S. aureus infections died. Although the
current study is hypothesis-generating and the exact pathophysiology remains
speculative, these findings raise concern that immune predispositions may adversely
impact the safety and efficacy of staphylococcal vaccines actively under
development. The potential benefits of an effective vaccine against S. aureus
justify continued but cautious pursuit of this elusive goal.
“In a blinded randomized trial, preoperative
receipt of the Merck V710 Staphylococcus
aureus vaccine was associated with a higher
mortality rate than placebo in patients who
later developed postoperative S. aureus infections.
Of the tested patients, all 12 V710 recipients
(but only 1 of 13 placebo recipients) with
undetectable serum IL2 levels prior to
vaccination and surgery died after
postoperative S. aureus infection.”
http://www.ncbi.nlm.nih.gov/pubmed/?term=25483690