GlycoVaxyn has announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs).
The investigational vaccine is being co-developed by GlycoVaxyn AG and Janssen Pharmaceuticals Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The first-in-human clinical study includes 180 women affected by recurrent UTI. It is a multicenter, placebo-controlled study conducted in Switzerland.
The primary aim is to assess the safety of the candidate vaccine. In addition, the immunogenicity, measured by the induction of bactericidal (opsonophagocytic) antibodies, will be determined. Finally, the serotype-specific efficacy of the vaccine will be evaluated. The glycoconjugate ExPEC vaccine was produced using GlycoVaxyn’s proprietary biological conjugation platform and contains surface polysaccharide antigens of the most predominant ExPEC strains.
Urinary tract infection (UTI) is the most common urological disease and one of the most frequent bacterial infections. Up to 50% of all women experience at least one UTI and 10-15% have recurrent UTI, which is a significant clinical problem in terms of morbidity, ongoing medical care, and associated health care costs.
ExPEC bacteria cause 80% of community-acquired UTIs and approximately 50% of hospital-acquired UTIs. Increasing resistance to antibiotics among ExPEC strains thereby reducing the efficacy of treatment emphasizes the need to develop preventative measures.
ExPEC bacteria are also a leading cause of invasive E.coli infectious diseases such as bacteremia, an increasing problem in the aging population and partly linked to increasing antibiotic resistance.
"We are very excited and proud to have initiated this trial within a very short period of time following our announced collaboration with Janssen and we believe that such a vaccine will bring important health benefits to patients who are chronically affected by this infection," said Dr. Veronica Gambillara , Head of Clinical and Regulatory affairs at GlycoVaxyn.
GlycoVaxyn’s biological conjugation platform enables the enzymatic conjugation of antigenic polysaccharides to protein carriers and therefore makes the development and commercialization of complex multivalent vaccines easier, faster and more reliable.