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New treatment option for Healthy Volunteer Study
Official title Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
ClinicalTrials.gov ID: NCT05847322
What this study is testing
What is Bordetella pertussis B1917?
Bordetella pertussis B1917 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for healthy volunteer study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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 treatment 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...
- 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
- Pregnancy, lactation or intention to become pregnant during the study
- Any clinically significant abnormal finding on biochemistry, haematology, toxicology or serological blood tests, urinalysis (see The following reference ranges are provided for the purpose of guidance only. Results that...
- Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or...
- Individuals living in the same households as:
- unimmunised or partially immunised children and infants aged \< 1 year
- pregnant women
- immunosuppressed individuals
- frail individuals
- healthcare workers 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 have been involved in other clinical trials involving receipt of an investigational product over the last 12 weeks or if there is planned use of an investigational product during the study period
- Individuals who have previously participated in a B. pertussis human challenge study
- Individuals who have a history of never being vaccinated against B. pertussis
- Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; malignancy, asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the...
- Contraindications to the use of azithromycin or macrolides
- Any clinically significant abnormal finding on clinical examination
- Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or...
- Pregnancy, lactation or intention to become pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- Southampton, Hampshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Southampton, Hampshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.