French clinical-stage specialty biopharmaceutical company DBV Technologies has begun enrolment for its proof of concept Phase I clinical trial of Viaskin rPT to treat Bordetella pertussis (whooping cough).
Bionet’s genetically detoxified pertussis toxin (rPT) is an optimised pertussis antigen intended to be delivered epicutaneously through DBV’s adjuvant-free patch technology, Viaskin.
Pertussis is an acute respiratory infection caused by small Gram-negative, aerobic bacteria known as bordetella pertussis.
It triggers symptoms such as severe, spasmodic coughing episodes during the paroxysmal phase.
The Phase I proof-of-concept study is conducted in association with the Clinical Research Centre of Geneva University Hospitals (HUG), under the supervision of Professor Claire-Anne Siegrist and BioNet-Asia.
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The dose-escalation, randomised, double-blind, placebo-controlled study intends to test the safety and immunogenicity of BioNet’s rPT through DBV’s Viaskin patches in 60 young healthy adults aged between 18-40 who have been vaccinated during childhood against pertussis.
The study will be divided into two cohorts with 30 patients each.
The first cohort will be treated with two dosages of rPT or placebo with the Viaskin patches applied for 48 hours with an interval of two weeks between each application.
After four weeks of the second Viaskin application, the subjects will receive a single dose of Boostrix dTpa vaccine to ensure activation of immunity against diphtheria, tetanus and the three pertussis antigens.
The secondary endpoint of the cohort is the evaluation of immune and cellular responses resulted by rPT.
The determination of the safety and tolerability of the first dose of Viaskin rPT 25 will pave the way for the initiation of treatment in the second cohort, which will treat the patients with two dosages of Viaskin rPT.
DBV Technologies chairman and CEO Dr Pierre-Henri Benhamou said: "Utilising the skin’s immune properties for vaccination is a paradigm shift in this field.
“Professor Siegrist and her team recently published a paper with pre-clinical data, showing that a single application of Viaskin rPT on intact skin was capable of reactivating whooping cough immunity without the use of adjuvants.
“This valuable collaboration with HUG and BioNet has the potential to be a breakthrough in vaccinations: if Professor Siegrist and her team can replicate the in vivo results in humans, Viaskin rPT could be the first non-invasive and self-administrable vaccine to be developed for boosting pertussis immunity."
