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Viaskin Pertussis Vaccine Trial

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ClinicalTrials.gov Identifier: NCT03035370
Recruitment Status : Unknown
Verified July 2017 by DBV Technologies.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
DBV Technologies

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.


Condition or disease Intervention/treatment Phase
Whooping Cough Biological: Viaskin PT 25 mcg Biological: Viaskin PT 50 mcg Biological: Viaskin PT Placebo Biological: Boostrix™ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 Start Date : September 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough

Arm Intervention/treatment
Experimental: Viaskin PT 25 mcg
Viaskin PT 25 mcg
Biological: Viaskin PT 25 mcg
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).

Biological: 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.

Experimental: Viaskin PT 50 mcg
Viaskin PT 50 mcg
Biological: Viaskin PT 50 mcg
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).

Biological: 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.

Placebo Comparator: Viaskin PT Placebo
Viaskin PT Placebo
Biological: Viaskin PT Placebo
Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).

Biological: 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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (AE). [ Time Frame: From Day 0 to Day 70. ]
    • 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.


Secondary Outcome Measures :
  1. PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies). [ Time Frame: Day 14, Day 28, Day 42, Day 70. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035370


Locations
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Switzerland
Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Geneva, Switzerland, 1211
Sponsors and Collaborators
DBV Technologies
University Hospital, Geneva
Investigators
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Principal Investigator: Claire Anne Siegrist, M.D Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology

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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03035370     History of Changes
Other Study ID Numbers: VBEST
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by DBV Technologies:
Pertussis
Epicutaneous ImmunoTherapy (EPIT)
Vaccine
Viaskin PT

Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs