Actively Recruiting
Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
Led by University of Southampton · Updated on 2025-04-08
72
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
- Provided written informed consent
- Willing to take antibiotic treatment if required by the study
- Willing to follow infection control guidelines during social contact
- Willing to attend the study center immediately if symptoms develop
- Agree to have no bedroom contacts other than their declared contact during the study
- Able to answer all questions on the pre-consent questionnaire correctly
You will not qualify if you...
- Living with unimmunised or partially immunised children or infants under 1 year
- Living with pregnant women over 32 weeks without recent pertussis vaccination
- Living with immunosuppressed or frail individuals
- Healthcare workers regularly working with vulnerable individuals
- Having commitments to be in close contact with vulnerable individuals during the study period
- Living in boarding schools or dormitories
- Bordetella pertussis detected on nasal wash before inoculation
- Confirmed or suspected infection at time of inoculation
- Participation in other interventional trials in last 12 weeks
- Received pertussis vaccine in last 5 years
- Previous participation in Bordetella pertussis human challenge studies
- Proven whooping cough infection in last 5 years
- Never vaccinated against pertussis
- Current smoker or recent vaping
- Use of systemic antibiotics within 30 days or during challenge
- Immunosuppressive or immune-deficient conditions including HIV or recent immunosuppressant medications
- Use of immunoglobulins or blood products within 3 months
- Allergic reactions likely to be worsened by inoculum
- Contraindications to azithromycin or macrolides
- Pregnancy, breastfeeding, or intention to become pregnant during study
- Clinically significant abnormal lab or clinical examination findings
- Any other significant disease or condition increasing risk or affecting study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NIHR Clinical Research Facility
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
R
Robert Read
CONTACT
D
Diane Gbesemete
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here