Establishing a Controlled Human Infection Model of Bordetella Pertussis

Pertussis Clinical Trial

Official title: Open-label, Phase 1, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining the Optimal and Safe Bordetella Pertussis Dose That Induces Mild Symptomatic Infection and Colonization in Healthy Adults

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a single-center trial to develop a Bordetella pertussis Controlled Human Infection Model (CHIM) using a two-study approach: the first study is a human infectious dose 70%-90% (HID70-90) identification study, and the second an HID70-90 dose confirmation study to verify and confirm that the infectious endpoint has been reached. The infectious endpoint is positive nasopharyngeal culture(s) and/or polymerase chain reaction(s) (PCR(s)) for B. pertussis with concurrent or subsequent development of mild pertussis disease symptoms such as rhinorrhea and cough within the 16-day inpatient period following challenge.

The trial is an open-label, phase 1, dose escalation, self-contained trial; participants will be allocated to challenge dose groups to receive a single intranasal dose of challenge inoculum. All participants will receive a 5-day course of azithromycin eradication therapy either 24-48 hours after they develop symptoms or at the end of the 16-day postchallenge observation period.

The optimal/target inoculum is one that induces mild symptomatic infection and detection of B. pertussis in nasopharyngeal cultures in 70%-90% of participants receiving it, to establish a safe and reproducible pertussis CHIM.

Safety monitoring includes close clinical observation during a 16-21-day inpatient postchallenge period in the Canadian Center for Vaccinology's Challenge Unit, a Data and Safety Monitoring Board, and participant Diary Cards. ;

Related Conditions & MeSH terms

• Infections
• Pertussis
• Whooping Cough

• NCT number: NCT05136599
• Study type: Interventional
• Source: Dalhousie University
• Contact: Kylie Peacock
• Phone: 902-470-8141
• Email: kylie.peacock@iwk.nshealth.ca
• Status: Recruiting
• Phase: Phase 1
• Start date: January 28, 2022
• Completion date: January 2025