DBV Technologies (NSDQ:DBVT) and BioNet-Asia said today that the independent Data & Safety Monitoring Board positively reviewed DBV’s needle-free vaccine patch technology, Viaskin, and that enrollment in a Phase I trial for booster immunization against pertussis will continue into the 2nd dosing cohort.
The Viaskin pertussis booster vaccination program will test the ability of DBV’s needle-free vaccine tech to epicutaneously deliver 2 different doses of BioNet’s genetically detoxified pertussis toxin, in the hopes of boosting immunity against whooping cough. The study enrolled 60 adults, ranging from 18 to 40 years old, who were vaccinated against pertussis as a child. The Viaskin patches will be applied for 48 hours, with a 2 week interval between applications.
The 1st dosing cohort received 2 applications of Viaskin at 25ųg or a placebo. Since the DSMB found no safety concerns with the 1st dosing cohort, the 2nd group of participants will receive 2 applications of Viaskin at 50ųg or a placebo. The Phase I randomized, double-blind proof of concept study is being conducted at the Clinical Research Center of the Geneva University Hospitals.
Although booster immunizations are recommended for adolescents and adults, compliance is not always high. Researchers hope a needle-free vaccine that is patient-friendly, painless and non-invasive could help increase compliance for booster immunizations.