NCT02453048

Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine

Phase Ib (High Dose), Single Centre, Dose-escalating, Placebo-controlled, Randomized Study of a Live Attenuated B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 32 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety and immunogenicity of a higher dose formulation of a new live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain BPZE1 given as a single intranasal dose to healthy adult volunteer.

Conditions

• Pertussis
• Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	BPZE1	Intranasal live, attenuated vaccine
OTHER	Placebo	Diluent

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2015-05-25
• Last updated: 2026-02-27
• Results posted: 2020-01-02

Locations

1 site across 1 country: Sweden