Clinical trial NCT03035370: Viaskin Pertussis Vaccine Trial
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 Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Whooping Cough
Keywords: Pertussis
Epicutaneous ImmunoTherapy (EPIT)
Vaccine
Viaskin PT
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Geneva
First posted: 2017-01-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (AE).
timeFrame: From Day 0 to Day 70.
Secondary outcomes:
measure: PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
timeFrame: Day 14, Day 28, Day 42, Day 70.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Study officials:
affiliation: Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
name: Claire Anne Siegrist, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.