DBV Technologies, the Geneva University Hospitals (HUG) and BioNet-Asia Co. Ltd on Thursday said that in a planned interim assessment of the Phase I trial of Viaskin rPT for booster immunization against Bordetella pertussis, the independent Data and Safety Monitoring Board (DSMB) concluded that there were no safety concerns with the administration of Viaskin rPT 25 mcg in the first subject cohort. Based on this review, enrollment in the trial has continued as planned, with dosing of Viaskin rPT 50 mcg beginning in the second subject cohort.
The Viaskin rPT pertussis booster vaccination program intends to test the ability of DBV’s needleless and adjuvant-free patch technology, Viaskin, to epicutaneously deliver two different doses of BioNet’s genetically detoxified, recombinant pertussis toxin for boosting immunity against whooping cough.
In the first dosing cohort, subjects received two applications of either Viaskin rPT 25 mcg or placebo. Following the DSMB’s positive recommendation, a second cohort of subjects will receive two applications of Viaskin rPT 50 mcg or placebo at two-week interval. This Phase I proof of concept study is being conducted under the supervision of Professor Claire-Anne Siegrist from the Clinical Research Center of HUG and is sponsored by DBV Technologies.