CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
BPZE1 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02453048
NCT02453048Phase 1Completed
CompareCT.gov

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

Institut National de la Santé Et de la Recherche Médicale, France·interventional·Posted May 25, 2015·Updated Feb 27, 2026

In Brief

A Phase 1 clinical trial evaluating BPZE1 and Placebo for Pertussis and Whooping Cough. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPertussis, Whooping Cough
CountriesSweden
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 25, 2015
Enrollment StartSep 1, 2015
Primary CompletionMar 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago

Interventions

BPZE1biological

Intranasal live, attenuated vaccine

Placeboother

Diluent