Vaccine against Toxic Shock Syndrome successfully tested in a Phase I trial

6/13/2016 5:55:08 PM

Toxic shock syndrome (TSS) is a rare, toxin-mediated condition with high morbidity and mortality. TSS results from the host's overwhelming inflammatory response and cytokine storm mainly due to superantigens. TSS typically starts with signs and symptoms similar to the flu, including fever, chills, muscle aches, headache, vomiting, dizziness, or lightheadedness when standing, or low blood pressure. TSS is also associated with a rash that looks like a sunburn and then spreads to a more sever rash over the palms of the hands and soles of the feet. Symptoms usually start suddenly and progress quickly.

Researchers from the Department of Clinical Pharmacology, Medical University Vienna, in collaboration with Biomedicinische Forschungsgesellschaft mbH in Vienna, have developed the world's most clinically advanced vaccine against TSS and successfully tested it in a Phase I trial. The vaccine, a recombinant detoxified toxic shock syndrome toxin-1 variant (rTSST-1v) from a Staphylococcus toxin, has been found to be immunogenic and well-tolerated in a clinical Phase I trial after being given to 46 young men and women. The vaccine is injected into the skin and its effect is similar to that of a tetanus vaccine. This study represents an important milestone in vaccine development to prevent a potentially lethal disease.

According to Professor Bernd Jilma (Medical University of Vienna), "Immunization with such vaccines lasts for 5 years or more. Once vaccinated, a person develops antibodies, which become active if the germs start to pose a threat. A blood test can show whether someone is short of antibodies. Risk groups could then be preventively vaccinated." A Phase II trial with a larger population has started. It will take several more years to finish clinical development (Phase II and Phase III trials), and a few more years for regulatory review and approval before the vaccine goes to the market.

TSS was first described in children in 1978. Subsequent reports identified an association between TSS and use of superabsorbent tampon by menstruating women. Menstrual TSS is more likely in women using tampons for more days of their cycle, and keeping in a single tampon in place for a longer period of time. Since manufacturers pulled certain types of tampons off the market, the incidence of TSS in menstruating women has declined. About half of the cases of TSS are not associated with menstruation. Non-menstrual cases of TSS usually complicate the use of barrier contraceptives, postpartum or surgical wound infections, cutaneous lesions, burns, osteomyelitis, and arthritis.

"Staphylococci colonize nearly all of us, especially 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 TSS", explains Martha Eibl, Director of Biomedizinische Forschungsgesellschaft mbH and former university professor at the Institute for Immunology of the Medical University Vienna. This affects dialysis patients, the chronically sick, people with liver disease and people recovering after heart operations.

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