Actively Recruiting
A Human Controlled Infection Study to Establish Safety of Infection With Bordetella Pertussis With Antibiotic Therapy Delayed for up to 6 Weeks
Led by University of Southampton · Updated on 2026-05-18
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and natural clearance of Bordetella pertussis colonisation in healthy adult volunteers aged 18 to 55 years. The study aims to understand how the bacteria colonise the nose after deliberate exposure and how the body’s immune system responds over time. The study also investigates the potential transmission of the bacteria to close contacts during this period. Volunteers in the challenge group will receive a nasal dose of Bordetella pertussis and be monitored weekly for six weeks. If colonisation is detected at week 5 or if symptoms appear earlier, participants will receive a three-day course of azithromycin to clear the bacteria. A separate contact group, consisting of bedroom sharers of the challenged volunteers, will also be monitored for transmission and treated similarly if colonised. Participants will attend weekly visits to assess safety, collect nasal wash samples for bacterial detection, and monitor immune responses through blood tests. The study measures include adverse events, bacterial colonisation density, and antibody levels. Infection control measures are required to prevent transmission to vulnerable individuals. Total study participation lasts for six weeks with close follow-up and antibiotic therapy as needed.
CONDITIONS
Brief Title
Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years inclusive on the day of screening
- Fully conversant in the English language
- Able to communicate easily by mobile phone, email, and text messaging
- Able and willing to comply with all study requirements
- Written informed consent provided
- Willing to take antibiotic treatment if required
- Willing to follow infection control guidelines during social contact
- Willing to attend the research facility immediately if symptoms develop
- Agree to have no bedroom contacts other than the designated contact volunteer during the study
- Able to correctly answer all questions on the pre-consent questionnaire
You will not qualify if you...
- Living with unimmunised or partially immunised children under 1 year old
- Living with pregnant women over 32 weeks without recent pertussis vaccination
- Living with immunosuppressed or frail individuals
- Healthcare workers regularly working with vulnerable people
- Having commitments to be in close contact with vulnerable individuals during the study
- Living in boarding schools or dormitories
- Bordetella pertussis detected before inoculation
- Confirmed or suspected infection at the time of inoculation
- Participation in other interventional trials within the last 12 weeks
- Bordetella pertussis vaccination in the last 5 years
- Previous participation in a B. pertussis human challenge study
- Proven B. pertussis infection in the last 5 years
- Never vaccinated against B. pertussis
- Current smokers or recent vaping
- Recent use of systemic antibiotics
- Immunosuppressive or immune-deficient conditions, including HIV
- Recent immunoglobulin or blood product use
- Allergic reactions to inoculum components
- Contraindications to azithromycin or macrolides
- Pregnancy, lactation, or intention to become pregnant during the study
- Significant abnormal lab or clinical findings
- Any other significant disease or condition increasing risk or affecting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Challenge volunteers receive a nasal inoculation with Bordetella pertussis and return weekly to monitor safety, colonisation, and immune responses.
Weekly visits for up to 6 weeks
Duration - 6 weeks
Contact volunteers are monitored for transmission by weekly assessments of colonisation with Bordetella pertussis.
Weekly visits for up to 6 weeks
Duration - 3 days
Participants who are colonised with Bordetella pertussis receive a 3-day course of azithromycin at week 6 or earlier if symptoms develop.
1 visit (in-person) for treatment administration
Trial Site Locations
Total: 1 location
1
NIHR Clinical Research Facility
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
R
Robert Read
D
Diane Gbesemete
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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