A Phase I Dose Escalation Randomized, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Reactivation of Pertussis Toxin Immunity With the Viaskin Epicutaneous Delivery System in Healthy Adults

Trial Profile

A Phase I Dose Escalation Randomized, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Reactivation of Pertussis Toxin Immunity With the Viaskin Epicutaneous Delivery System in Healthy Adults

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Sep 2018

At a glance

  • Drugs Pertussis acellular vaccine (Primary) ; DTaP vaccine
  • Indications Pertussis
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors DBV Technologies
  • Most Recent Events

    • 16 Sep 2018 Status changed from active, no longer recruiting to completed, according to a DBV Technologies media release.
    • 05 Sep 2018 According to a DBV Technologies media release, following the review of preliminary data released in 2017, DBV, HUG and BioNet added in cohorts 3 and 4 to receive Viaskin-PT following preparation of the skin with an epidermal laser (P.L.E.A.S.E., Pantec) before each patch application.
    • 05 Sep 2018 According to a DBV Technologies media release, this phase I, proof of concept study was conducted under the supervision of Prof. Siegrist from the Clinical Research Center of HUG in collaboration with DBV Technologies and BioNet-Asia.The Company continues to evaluate the positive proof of concept results of this study to determine potential next steps in vaccination.
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