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
Status
Completed
Conditions
Intervention / Treatment
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
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Geneva, Switzerland, 1211
- Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
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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 |
|---|---|
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EXPERIMENTAL: Viaskin PT 25 mcg
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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.
|
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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
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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 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events (AE).
Time Frame: From Day 0 to Day 70.
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From Day 0 to Day 70.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
Time Frame: Day 14, Day 28, Day 42, Day 70.
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Day 14, Day 28, Day 42, Day 70.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- VBEST
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.