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Establishing a Controlled Human Infection Model of Bordetella Pertussis

NCT05136599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-08-13

No results posted yet for this study

Summary

This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults.

Conditions

  • Pertussis

Interventions

BIOLOGICAL

Bordetella pertussis D420

Intranasal inoculation of Bordetella pertussis D420 in each naris on Day 0 of the study.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Centers for Disease Control and Prevention

    collaborator FED

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Scott A. Halperin, MD · Dalhousie University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2025-03-14
Completion
2025-03-14
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

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 NCT05136599 on ClinicalTrials.gov