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
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedStudy Start
First participant enrolled
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2018
CompletedMarch 2, 2020
February 1, 2020
1.6 years
March 15, 2016
February 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (AE).
* 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 Outcomes (1)
PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
Day 14, Day 28, Day 42, Day 70.
Study Arms (3)
Viaskin PT 25 mcg
EXPERIMENTALViaskin PT 25 mcg
Viaskin PT 50 mcg
EXPERIMENTALViaskin PT 50 mcg
Viaskin PT Placebo
PLACEBO COMPARATORViaskin PT Placebo
Interventions
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
Two applications of Viaskin PT Placebo 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
- University Hospital, Genevacollaborator
Study Sites (1)
Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Geneva, 1211, Switzerland
Related Publications (1)
Chatzis O, Blanchard-Rohner G, Mondoulet L, Pelletier B, De Gea-Hominal A, Roux M, Huttner A, Herve PL, Rohr M, Matthey A, Gutknecht G, Lemaitre B, Hayem C, Pham HT, Wijagkanalan W, Lambert PH, Benhamou PH, Siegrist CA. Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial. Clin Microbiol Infect. 2021 Jun;27(6):878-885. doi: 10.1016/j.cmi.2020.08.033. Epub 2020 Sep 5.
PMID: 32896653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire Anne Siegrist, M.D
Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
January 30, 2017
Study Start
September 5, 2016
Primary Completion
April 25, 2018
Study Completion
April 25, 2018
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share