Viaskin Pertussis Vaccine Trial

Status Completed

Clinical Trial Summary

The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or 50 mcg PT protein compared to Viaskin placebo.

Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be assessed throughout the 10-week study and its immunogenicity will be assessed at regular intervals with collection of blood samples for immunological analyses.

Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Whooping Cough

Clinical Trial Details

NCT number	NCT03035370
Study type	Interventional
Source	DBV Technologies
Contact
Status	Completed
Phase	Phase 1
Start date	September 5, 2016
Completion date	April 25, 2018

View Details

See also
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