First Vaccine Developed Against Toxic Shock Syndrome

To test the vaccine, the researchers conducted a randomized phase I first-in-human trial in 46 healthy adults aged 18-64 years. The participants were randomly assigned to receive increasing doses of rTSST-1v or an adjuvant placebo of aluminium hydroxide (Al(OH)3).

The per-protocol population received a booster immunization 42 days after the first vaccination, with the primary endpoint being safety and tolerability of rTSST-1v. The results showed that rTSST-1v had a good safety profile, and no vaccination-related severe or serious adverse events occurred. Adverse event rates were similar between participants who received rTSST-1v and those who received placebo, independent of pre-existing TSST-1 immunity. The study was published on June 10, 2016, in Lancet Infectious Diseases.

“Staphylococci colonize nearly all of us, especially on our skin and mucous membranes. They are totally harmless to most people. However, for people with weakened immune systems, they can cause serious diseases such as Toxic Shocks Syndrome,” said senior author Professor Martha Eibl, PhD, director of Biomedizinische Forschungs. “This affects dialysis patients, the chronically sick, people with liver diseases, and people recovering after heart operations.”

TSS is a potentially fatal illness caused by a bacterial toxin. The causative bacteria include Staphylococcus aureus, and Streptococcus pyogenes. TSS resulting from infection with the bacterium Staphylococcus aureus typically manifests in otherwise healthy individuals with high fever, accompanied by low blood pressure, malaise and confusion, which can rapidly progress to stupor, coma, and multiple organ failure. TSS was first described in the 1980s, when general symptoms of sepsis or blood poisoning occurred in young women who had used so-called "super tampons" during their periods.

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