Viaskin Pertussis Vaccine Trial

February 28, 2020 updated by: DBV Technologies

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Geneva, Switzerland, 1211
        • Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has provided written informed consent before enrollment;
  • Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment;
  • Non-pregnant, non-lactating female;
  • Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
  • With documented history of pertussis immunization (at least 4 doses);
  • Women of childbearing potential with a negative pregnancy test at entry;
  • Females of childbearing potential who are willing to use an effective method of contraception.

Exclusion Criteria:

  • Prior dTpa immunization within the last 10 years or prior dT immunization within the last 2 years, or any other investigational vaccine likely to impact on interpretation of the trial data;
  • Suspected or confirmed pertussis infection within the last 10 years or documented pertussis infection in a household member within the last 10 years;
  • Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Viaskin PT 25 mcg
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
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.
EXPERIMENTAL: Viaskin PT 50 mcg
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.
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
PLACEBO_COMPARATOR: Viaskin PT Placebo
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.
Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Day 0 to Day 70.

Secondary Outcome Measures

Outcome Measure
Time Frame
PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
Time Frame: Day 14, Day 28, Day 42, Day 70.
Day 14, Day 28, Day 42, Day 70.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claire Anne Siegrist, M.D, Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2016

Primary Completion (ACTUAL)

April 25, 2018

Study Completion (ACTUAL)

April 25, 2018

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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