Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B.
pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after
inoculation or at symptom onset, whichever occurs first
Secondary objectives - To measure the rate of natural clearance of carriage of B. pertussis
following nasal inoculation
- To assess the kinetics of B. pertussis colonisation density following nasal inoculation
- To describe the microevolution of B. pertussis and adaptation of the resident microbiome
during B. pertussis carriage
- To measure B. pertussis-specific antibody and cellular immunological responses in
healthy volunteers during colonisation with B. pertussis - To identify biomarkers that
correlate with natural clearance of B. pertussis carriage after induced B. pertussis
colonisation
- To detect transmission of B. pertussis to bedroom contacts of inoculated volunteers
during prolonged asymptomatic colonisation