About this trial
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
Eligibility criteria
Qualifiers
Healthy adults aged 18 to 55 years inclusive on the day of screening
Fully conversant in the English language
Able to communicate easily by both mobile telephone, email and text messaging
Able and willing (in the investigator's opinion) to comply with all study requirements
Disqualifiers
unimmunised or partially immunised children and infants aged < 1 year
pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact
immunosuppressed individuals
frail individuals
Trial design
Treatments tested in this trial
- Bordetella pertussis B1917
- Azithromycin Pill