At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bordetella pertussis B1917 (biological), Azithromycin Pill (drug)
- How long the study runs
- Study runs about 45 months (dates as stated)
- About the drug or intervention
- Bordetella pertussis B1917 — biological: The B. · Azithromycin Pill — drug: A 3 day course of azithromycin will be administered to all colonised volunteers at week 6, or sooner if early pertussis disease is suspected
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 55 Years
- Who
- All
- Number of participants
- 19
- Started
- 2022-12-06
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for healthy volunteer study
- • NA - 19 participants
- • Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B
Who can take part?
- • Ages 18 Years to 55 Years
- • Diagnosed with healthy volunteer study
Where?
- • Southampton - NIHR Clinical Research Facility
This is a simplified summary. Always discuss with your doctor before making any decisions.
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
More detail
This is a prospective controlled human challenge study; Challenge group: The challenge volunteers will be healthy volunteers, aged 18-55 years, not having close contact with people having increased risk of severe pertussis complications or increased risk of transmitting to vulnerable individuals. Eligible volunteers must be willing to abide by infection control measures during social contact and to attend immediately if they become symptomatic. People who live in institutions in which multiple people share dormitory facilities, such as boarding schools or military barracks will be excluded. The standard inoculum, a dose of 105 cfu, determined in Phase A of the Bp human challenge study, will be used. Participants will be followed up weekly and colonisation will be measured in nasal washes. If culture of the nasal wash taken at week 5 following nasal inoculation is positive for B. pertussis, then eradication therapy will be given at week 6. Early eradication therapy will be given if a participant presents with symptoms of early B. pertussis disease. Recruitment will continue until 10 challenge volunteers have been colonised and then completed study participation to week 6 as per protocol. Volunteers who withdraw from the study early or have colonisation cleared with antibiotic treatment given for any reason will be replaced. Assuming a colonisation fraction of at least 30% and allowing for study withdrawal the investigator expect a maximum number of 36 volunteers to be inoculated. Contact group: A group of contact volunteers, maximum 36 individuals, will be enrolled to assess transmission by monitoring for colonisation with the challenge strain of B. pertussis. These contact volunteers will be bedroom sharers of challenge volunteers and will give informed consent for their participation in the study, prior to inoculation of the corresponding challenge volunteer. Eradication therapy will be given at week 6 if the culture of nasal wash is positive for B. pertussis at week 5. Early eradication therapy will be given if a contact volunteer presents with symptoms of early B. pertussis disease. Challenge and contact volunteers will be required to agree to infection control measures prior to enrolment in the study. Part of this agreement will be to refrain from bedroom sharing or intimate contact with any individual other than one declared and consented bedroom contact. They will avoid contact with children or people vulnerable to whooping cough such as unimmunised or partially immunised children and infants aged \< 1 year, and pregnant women.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 55 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ according to the study protocol
What the study is looking for
- ✓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 agreement to take part to participate in the study
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
NIHR Clinical Research Facility
Southampton SO16 6YD, United Kingdom
