Date: 2015-01-21
Type of information: Interim results
phase: 1
Announcement: interim results
Company: GlycoVaxyn (Switzerland) Janssen Pharmaceutical, a J&J Company (USA)
Product: EXPEC vaccine
Action
mechanism: The glycoconjugate ExPEC vaccine was produced using GlycoVaxyn\'s proprietary biological conjugation platform and contains surface polysaccharide antigens of the most predominant ExPEC strains.
Disease: infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs)
Therapeutic area: Infectious diseases
Country: Switzerland
Trial
details: 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.
Latest
news: * On January 21, 2015, GlycoVaxyn announced that it has received the first milestone in its clinical co-development with Janssen Pharmaceuticals, of the vaccine candidate aimed to prevent infections caused by Extraintestinal Pathogenic Escherichia coli (ExPEC).
The clinical milestone is linked to the achievement of a robust immune-response against all antigens included into the vaccine candidate at 30 days post-vaccination. ExPEC bacteria are a leading cause of adult bacteremia. The induction of bactericidal (opsonophagocytic) antibodies, a well-known protective mechanism against bacteremia, is being measured in the ongoing clinical study. The first-in-human, placebo-controlled, randomized multicenter study currently conducted in Switzerland includes 194 women affected by recurrent urinary tract infections (UTIs). The primary aim is to assess the safety and immunogenicity of the vaccine candidate, including the measurement of bactericidal antibodies.
* On July 1, 2014, GlycoVaxyn 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.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.
