Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Southampton

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

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators