At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Bordetella pertussis D420 for Pertussis. Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Interventions
Intranasal inoculation of Bordetella pertussis D420 in each naris on Day 0 of the study.