Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
Recruiting now · Not applicable
Conditions studied: Healthy Volunteer Study
In brief
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
Key facts
- Study ID
- NCT05847322
- Run by
- University of Southampton
- People needed
- 72
- Starts
- 2022-12-06
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Written informed consent to participate in the study
- Willingness to take a curative antibiotic regimen if / when required according to the study protocol
- Willingness to abide by infection control guidelines during social contact for the duration of their participation in the study
- Willingness to attend to the National Institute for Health Research (NIHR) Clinical Research Facility (CRF) Southampton immediately if they become symptomatic
- Agreement to have no bedroom contacts other than their corresponding contact/challenge volunteer between inoculation and 6 weeks after inoculation
- Able to answer all questions on the pre-consent questionnaire correctly
You may not qualify if…
- Individuals living in the same households as:
- 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
- healthcare workers regularly working with vulnerable individuals as above
- Individuals who have inviolable commitments within the study period (from day 0 to week 6 + 2 days) to be in close contact with:
- 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
- Individuals who live in a boarding school or dormitory during the study.
- B. pertussis detected on nasal wash taken before the initial challenge
- Individuals with a confirmed or suspected infection at the time of inoculation with B. pertussis
- Individuals who have participated in other interventional clinical trials in the last 12 weeks
- Individuals who have a history of receiving B. pertussis vaccination in the last 5 years
- Individuals who have previously participated in a B. pertussis human challenge study
- Individuals who have had a proven B. pertussis infection in the last 5 years
- Individuals who have a history of never being vaccinated against B. pertussis
- Current smokers defined as having had a cigarette/cigar in the last week (including vaping)
- Use of systemic antibiotics within 30 days of or during the challenge
- Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
- History of allergic disease or reactions likely to be exacerbated by any component of the inoculum
- Contraindications to the use of azithromycin or macrolides
Where it is running
- NIHR Clinical Research Facility — Southampton, Hampshire, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.