Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
102 participants
INTERVENTIONAL
2016-09-05
2018-04-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Viaskin PT 25 mcg
Viaskin PT 25 mcg
Viaskin PT 25 mcg
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
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.
Viaskin PT 50 mcg
Viaskin PT 50 mcg
Viaskin PT 50 mcg
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
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.
Viaskin PT Placebo
Viaskin PT Placebo
Viaskin PT Placebo
Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).
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.
Interventions
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Viaskin PT 25 mcg
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
Viaskin PT 50 mcg
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
Viaskin PT Placebo
Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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University Hospital, Geneva
OTHER
DBV Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Claire Anne Siegrist, M.D
Role: PRINCIPAL_INVESTIGATOR
Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
Locations
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Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Geneva, , Switzerland
Countries
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References
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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.
Other Identifiers
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VBEST
Identifier Type: -
Identifier Source: org_study_id
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