Back to results

Viaskin Pertussis Vaccine Trial

Primary Purpose

Whooping Cough

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Viaskin PT 25 mcg

Viaskin PT 50 mcg

Viaskin PT Placebo

Boostrix™

About this trial

This is an interventional other trial for Whooping Cough focused on measuring Pertussis, Epicutaneous ImmunoTherapy (EPIT), Vaccine, Viaskin PT

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Viaskin PT 25 mcg

Viaskin PT 50 mcg

Viaskin PT Placebo

Arm Description

Viaskin PT 25 mcg

Viaskin PT 50 mcg

Viaskin PT Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03035370

First Posted

March 15, 2016

Last Updated

February 28, 2020

Sponsor

DBV Technologies

Collaborators

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT03035370

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 5, 2016 (Actual)

Primary Completion Date

April 25, 2018 (Actual)

Study Completion Date

April 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DBV Technologies

Collaborators

University Hospital, Geneva

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Whooping Cough

Keywords

Pertussis, Epicutaneous ImmunoTherapy (EPIT), Vaccine, Viaskin PT

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viaskin PT 25 mcg

Arm Type

Experimental

Arm Description

Viaskin PT 25 mcg

Arm Title

Viaskin PT 50 mcg

Arm Type

Experimental

Arm Description

Viaskin PT 50 mcg

Arm Title

Viaskin PT Placebo

Arm Type

Placebo Comparator

Arm Description

Viaskin PT Placebo

Intervention Type

Biological

Intervention Name(s)

Viaskin PT 25 mcg

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Viaskin PT 50 mcg

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Viaskin PT Placebo

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Boostrix™

Intervention Description

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 Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (AE).

Description

Time Frame

From Day 0 to Day 70.

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 14, Day 28, Day 42, Day 70.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire Anne Siegrist, M.D

Organizational Affiliation

Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

32896653

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.

Results Reference

derived

Learn more about this trial

Viaskin Pertussis Vaccine Trial

We'll reach out to this number within 24 hrs