Researchers from MedUni Vienna's Department of Clinical Pharmacology, in collaboration with Biomedizinische Forschungsgesellschaft in Vienna, have developed what they claim is the world's first safe and effective vaccine against TSS and have successfully tested it in a Phase I trial.
The results were recently published in the journal, The Lancet Infectious Diseases.
This syndrome was first described in the 1980s. General symptoms of sepsis or blood poisoning occurred in young women who had used so-called 'super tampons' during menstruation. This is why the syndrome was also known as 'tampon disease'. This subsequently led to the absorption capacity of tampons being regulated.
Staphylococci colonise nearly all of us, especially on our skin and mucous membranes. They are totally harmless to most people.
A Phase II trial with a larger test population has now started
'However, for people with weakened immune systems, they can cause serious diseases such as toxic shock syndrome,' says Martha Eibl, Director of Biomedizinische Forschungsgesellscaft and a former university professor at the Institute for Immunology of the medical faculty of the University of Vienna. TSS generally affects dialysis patients, the chronically sick, people with liver diseases and people recovering after heart operations.
'Nevertheless, in 50% of cases the disease is associated with menstruation in young women,' says Bernd Jilma from MedUni Vienna's Department of Clinical Pharmacology.
The vaccine, which has been found to be safe and effective – and to have practically no side effects – is in a clinical Phase I trial, and has been tested on 46 young men and women. It was developed from a detoxified Staphylococcus toxin. The vaccine is injected into the skin and its effect is similar to that of a tetanus vaccination, says Jilma. 'Immunisation with such vaccines lasts for five 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 preventatively vaccinated.
'We are well on the way to having a vaccine that prevents this serious disease. However, it will still take some years before it is in clinical use,' says Eibl.
A Phase II trial with a larger test population has now started to check the initial, promising results and more volunteers are being sought.
