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Viaskin Pertussis Vaccine Trial

NCT03035370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Viaskin PT 25 mcg

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

BIOLOGICAL

Viaskin PT 50 mcg

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

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.

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • DBV Technologies

    lead INDUSTRY

Principal Investigators

  • Claire Anne Siegrist, M.D · Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2018-04-25
Completion
2018-04-25

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035370 on ClinicalTrials.gov