Viaskin Pertussis Vaccine Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Whooping Cough

Intervention / Treatment
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* Biological: Viaskin PT 25 mcg
* Biological: Viaskin PT 50 mcg
* Biological: Viaskin PT Placebo
* Biological: Boostrix™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viaskin PT 25 mcg<br>Viaskin PT 25 mcg | Biological: Viaskin PT 25 mcg<br>* Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).<br>Biological: Boostrix™<br>* 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.<br>|
| Experimental: Viaskin PT 50 mcg<br>Viaskin PT 50 mcg | Biological: Viaskin PT 50 mcg<br>* Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).<br>Biological: Boostrix™<br>* 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.<br>|
| Placebo Comparator: Viaskin PT Placebo<br>Viaskin PT Placebo | Biological: Viaskin PT Placebo<br>* Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).<br>Biological: Boostrix™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Epicutaneous ImmunoTherapy (EPIT), Vaccine, Viaskin PT