NCT06827470

Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis

Open-label, Phase 1/2, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining and Confirming the Optimal and Safe J820 Bordetella Pertussis Dose Administered Intranasally to Healthy Adults 18-50 Years of Age That Induces Mild Symptomatic Infection and Detection of B. Pertussis in Nasal Samples

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dalhousie University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.

Conditions

• Pertussis (Whooping Cough)

Interventions

Type	Name	Description
BIOLOGICAL	Biological: Bordetella pertussis J820	Intranasal inoculation of Bordetella pertussis J820 in each naris on Day 1 of the study.

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-12-31
• Completion: 2027-04-30
• First posted: 2025-02-14
• Last updated: 2025-12-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study