DBV Technologies, the Geneva University Hospitals (HUG) and BioNet-Asia have announced results from a Phase I trial assessing Viaskin rPT`s ability to boost immunity against pertussis by epicutaneously administering two doses of BioNet`s recombinant pertussis toxin.
The study evaluated the safety and immunogenicity of Viaskin where the primary endpoint was the incidence of treatment-emergent adverse events (AEs) related to the application of Viaskin rPT, and secondary objectives assessed humoral responses compared to placebo, the researchers said.
After further analysis of the data, limitations in the study design and protocol were observed. DBV, HUG and BioNet continue to review preliminary study data, and are evaluating if further development pathways, including optimization of Viaskin rPT, will be explored, DBV said in its press release.
“We have seen promising preclinical data showing significant immunogenicity with Viaskin rPT. We can now take key learnings from this first clinical trial attempt, and implement the necessary improvements needed to potentially conduct more informative studies and improve the immunogenicity of Viaskin rPT in the future,” said Professor Claire-Anne Siegrist, Director of the Center of Vaccinology of HUG. “The application of the novel Viaskin technology platform in immunization enables us to explore potential areas of development for patients that are currently being underserved by approved vaccines today.”