NCT01188512

First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine

A Phase 1, Single Centre, Dose-escalating, Placebo-controlled Study of a Genetically Modified B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: Male
• Age: 19 Years – 31 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers. Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most vulnerable age group), preferably after a single administration very early in life. The successful outcome of this project would constitute an important milestone towards nasal vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our ultimate aim is to protect infants in the most vulnerable age group, before the regular vaccination schedule using already available vaccines is applied. The ultimate aim is thus not to replace current vaccination schedules with available vaccines, but to add a first nasal vaccination to protect very early in life.

Conditions

• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	BPZE1	Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
BIOLOGICAL	Placebo	Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-06-01
• Completion: 2012-01-01
• First posted: 2010-08-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: Sweden