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news.GlycoVaxyn has concluded the Phase I study of its Shigella dysenteriae bioconjugate vaccine and met the primary and secondary endpoints that is demonstration of safety and immunogenicity.
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In the Phase I trial the female and male subjects were randomly assigned to one of the four groups receiving ascending antigen dose with or without adjuvant which were given at 60 days interval.
Reportedly, the results showed that the majority of the volunteers achieved good immune response.
Additionally, 80% of the volunteers exhibited a minimum of a four-fold increase of their antibody levels compared to their own pre-vaccination level.
In the trial, all vaccine dose levels tested elicited significant IgG as well as IgA antibody responses.
GlycoVaxyn CEOPhilippe Dro said that their vaccine shows a higher percentage of seroconversion compared to previous Shigella dysenteriae vaccines tested in clinical trials.
GlycoVaxyn chairman Michel Greco said that 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 disease.