Date: 2016-11-17
Type of information: Interim results
phase: 1
Announcement: interim results
Company: DBV Technologies (France) Geneva University Hospitals (Switzerland) BioNet-Asia (Thailand)
Product: Viaskin rPT®
Action
mechanism: immunotherapy product.
Disease: reactivation of immunity against Bordetella pertussis (whooping cough)
Therapeutic area: Infectious diseases
Country: Switzerland
Trial
details: This Phase I dose-escalation, randomized, double-blind, placebo-controlled safety and immunogenicity study is assessing the safety of BioNet’s genetically-detoxified recombinant pertussis toxin administered by DBV’s Viaskin patches in 60 young healthy adults.
Secondary endpoints will assess the patients’ humoral responses elicited by Viaskin rPT 25 ?g and 50 ?g compared to placebo. Immune cellular responses will also be monitored as exploratory endpoints. The trial is being conducted in the Clinical Research Center of the Geneva University Hospitals. Men and women aged 18 to 40 years who have been vaccinated during childhood against pertussis will be randomized into two cohorts of 30 subjects each. The Viaskin patches will be applied for 48 hours, with a two-week interval between applications. Four weeks after the second Viaskin application, participants will receive one dose of Boostrix® dTpa vaccine to ensure the recall of immunity against diphtheria, tetanus and the three pertussis antigens (only a single antigen will be delivered through Viaskin rPT). All subjects will be observed after each application. Local and systemic adverse events will be monitored. The first cohort has received two applications of Viaskin rPT 25 ?g or placebo. Following a positive DSMB review, dosing in the second patient cohort, which is expected to receive two applications of Viaskin rPT 50 ?g or placebo has commenced. (NCT03035370)
Latest
news: * On November 17, 2016, DBV Technologies, the Geneva University Hospitals (HUG) and BioNet-Asia announced 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 ?g in the first subject cohort. Based on this review, enrollment in the trial has continued as planned, with dosing of Viaskin rPT 50 ?g commencing in the second subject cohort. The Viaskin rPT pertussis booster vaccination program intends to test the ability of DBV’s needleless and adjuvantfree patch technology, Viaskin, to epicutaneously deliver two different doses of BioNet’s genetically detoxified, recombinant pertussis toxin for boosting immunity against whooping cough. * On September 6, 2016, DBV Technologies, the Geneva University Hospitals and BioNet-Asia announced that the first subject has been enrolled in a proof of concept Phase I clinical trial testing Viaskin rPT in the reactivation of immunity against Bordetella pertussis (whooping cough) in healthy adults. This pertussis vaccination program intends to test the ability of DBV’s needleless and adjuvant-free patch technology, Viaskin, to epicutaneously deliver two doses of BioNet’s genetically detoxified, recombinant pertussis toxin (rPT) to boost immunity against whooping cough.
