Trials / Completed
CompletedNCT03035370
Viaskin Pertussis Vaccine Trial
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- DBV Technologies · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Viaskin PT 25 mcg | Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14). |
| BIOLOGICAL | Viaskin PT 50 mcg | Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14). |
| BIOLOGICAL | Viaskin PT Placebo | Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14). |
| BIOLOGICAL | Boostrix™ | 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. |
Timeline
- Start date
- 2016-09-05
- Primary completion
- 2018-04-25
- Completion
- 2018-04-25
- First posted
- 2017-01-30
- Last updated
- 2020-03-02
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03035370. Inclusion in this directory is not an endorsement.