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Completed

NCT Number: NCT03035370

Viaskin Pertussis Vaccine Trial

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.

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Key information

Conditions

Whooping Cough Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viaskin PT 25 mcg

Biological

Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).

Viaskin PT 50 mcg

Biological

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

Viaskin PT Placebo

Biological

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

Boostrix™

Biological

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 outcomes

  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 outcomes

  1. PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).

    Time frame: Day 14, Day 28, Day 42, Day 70.

Sponsors and collaborators

Lead sponsor

DBV Technologies

Industry

Collaborators

  • University Hospital, Geneva

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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