Clinical Trial: Viaskin Pertussis Vaccine Trial
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: DBV Technologies
Current Primary Outcome: Incidence of Treatment-Emergent Adverse Events (AE). [ Time Frame: From Day 0 to Day 70. ]
- Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application;
- Unsolicited AEs from the time of application through 28 days following the 1st application;
- Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
Original Primary Outcome: Same as current
Current Secondary Outcome: PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies). [ Time Frame: Day 14, Day 28, Day 42, Day 70. ]
Original Secondary Outcome: Same as current
Information By: DBV Technologies
Dates:
Date Received: March 15, 2016
Date Started: September 2016
Date Completion: April 2017
Last Updated: January 25, 2017
Last Verified: January 2017
