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

NCT01188512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-10

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Swedish Institute for Infectious Disease Control

    collaborator OTHER

  • Innogenetics

    collaborator UNKNOWN

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Camille Locht, PhD · Institut National de la Santé Et de la Recherche Médicale, France

  • Nabil Al-Tawil, MD, PhD · Karolinska Trial Alliance

  • Rigmor Thorstensson, PhD · Swedish Institute for Infectious Disease Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
31 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-06-30
Completion
2012-01-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

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 NCT01188512 on ClinicalTrials.gov