The NeoStrep project will develop a novel vaccine against Group B Streptococcal (GBS) infections, responsible for 50% of life-threatening infections in newborns. The aim is to provide a safe and effective alternative to current generally implemented antibiotic prophylaxis. Emergence of clinical isolates of GBS with reduced susceptibility to penicillin (the preferred prophylactic antibiotic) and pattern of genetic mutations in penicillin binding proteins of GBS is identical to that observed in Streptococcus pneumoniae prior to the breakthrough of true widespread penicillin resistance in that pathogen. Combined with already existing resistance to a wide range of other antibiotics, this indicates current GBS antibiotic prophylaxis is highly vulnerable to antibiotic resistance. Emergence of widespread antibiotic resistance threatens to return the incidence of GBS disease to pre-prophylaxis levels with the associated significant increases in health cost and morbidity/mortality caused by infections with resistant GBS.
The NeoStrep project aims to eliminate the use of prophylactic antibiotics in GBS prevention and hence the problem of emerging antibiotic resistance in GBS through the development of a GBS vaccine.
No approved vaccine currently exists, and one currently in development only covers a subset of clinical serotypes. The NeoStrep vaccine, which is based on a novel fusion protein approach, has a wider serotype coverage (95%) and is much cheaper to manufacture than the other GBS vaccine candidate in development. The vaccine is extensively validated in animal models, and a simple production method has been developed.
The objective of the project is therefore to advance the vaccine through cGMP production, tox studies and into clinical trials, with the aim of generating proof of concept in humans by means of immunogenicity, response rate, durability and effect on spontaneous vaginal colonisation.
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