Phase I study of Shigella dysenteriae bioconjugate vaccine meets primary, secondary endpoints

Oct 8 2010

GlycoVaxyn AG, a leader in the development of innovative vaccines, announced today that the Phase I study of its Shigella dysenteriae bioconjugate vaccine has been completed and met the primary and secondary endpoints: demonstration of safety and immunogenicity.

“We are very pleased with these Phase I data”

The study in forty healthy volunteers assessed the safety, tolerability and antibody response to the bioconjugate vaccine and was conducted at the Institute for Social and Preventive Medicine of the University of Zürich, Switzerland, under the supervision of principal investigators Professors Hatz and Steffen. The female and male subjects were randomly assigned to one of the four groups receiving ascending antigen dose with or without adjuvant. Two vaccinations were given at 60 days interval.

The candidate vaccine exhibited a good safety profile. No significant adverse reactions were observed at any of the vaccine dose levels.

In addition, the results showed that the majority of the volunteers achieved robust immune response. Eighty percent of the volunteers exhibited a minimum of a four-fold increase of their antibody levels compared to their own pre-vaccination level. All vaccine dose levels tested elicited significant IgG as well as IgA antibody responses.

"We are very pleased with these Phase I data," said Philippe Dro, CEO of GlycoVaxyn. "This is the first time that a biologically synthesized conjugate vaccine has been tested in humans. Our vaccine shows a higher percentage of seroconversion compared to previous Shigella dysenteriae vaccines tested in clinical trials."

Shigellosis is a severe diarrheal condition resulting from bacterial infection. Each year, 1 million people are estimated to die from Shigella infection and 580,000 cases of shigellosis are reported among travellers from industrialized countries.

"This is a first step towards the development of a multivalent Shigella vaccine where additional serotypes will be included to provide a broad coverage against this severe diarrheal disease. It opens up significant partnering opportunities for the company." said Michel Greco, Chairman of GlycoVaxyn.