Bio&Bio’s toxic shock syndrome vaccine research concluded

Positive results showed the TSST-1 vaccine is effective with immunisation lasting for at least two years

Bio&Bio’s vaccine to treat staphylococcal-induced toxic shock syndrome (TSS) has completed its phase 2 study.

The company, in partnership with MedUni Vienna’s Department of Clinical Pharmacology, underwent a widespread clinical study. Positive results showed the TSST-1 vaccine is effective and safe, with immunisation lasting for at least two years.

Furthermore, researchers at Bio&Bio have identified a class of toxins which are linked to TSS and may play a critical role across other diseases triggered by staphylococci, notably septic shock.

The research is currently undergoing a peer review process, with the completed analysis due to be published in scientific journals.

Meanwhile, detoxified variants of toxins responsible for various forms of toxic shock syndrome are due to be combined into a multi-component vaccine. Indeed, studies with the multi-component vaccine are already being planned.

Dr Andreas Roetzer, head of R&D for vaccines at Bio&Bio, reflected: “With highly encouraging data from the phase 2 study building on a successful phase 1, we believe the TSST-1 vaccine could represent a real breakthrough in protecting these groups, as well as medical workers in at-risk settings.

“We look forward to publication of the full data and to moving TSST-1 into a pivotal phase 3 trial.”

Professor Dr Bernd Jilma of MedUni Vienna’s Department of Clinical Pharmacology, explained: “After vaccination with TSST-1, individuals develop antibodies that are protective as germs become dangerous. The vaccination is effective irrespective of whether or not strains are resistant to antibiotics.”

He added: “A simple blood test can be used to determine whether someone has low antibody levels, enabling people at risk to be vaccinated preventatively.”

Staphylococci poses a considerable health risk, with menstrual TSS accounting for around half of the total cases.

TSS is a life-threatening disease caused by toxins that can ultimately lead to multiple organ failure and death. Preparation for a phase 3 study of the vaccine is underway.