Healthy Volunteer StudyNCT05847322
Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
A study testing Bordetella pertussis B1917 and Azithromycin Pill in people with Healthy Volunteer Study, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Bordetella pertussis B1917 and Azithromycin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2022to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 47Show fewer
- 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
- 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 fall outside of these ranges may not be of clinical significance but should be considered on an individual basis.) or clinical examination - in the event of abnormal test results, confirmatory repeat tests will be requested
- 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 impair interpretation of the study data, for example recent surgery to the nasopharynx
- 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 past 6 months (topical steroids are allowed)
- 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 impair interpretation of the study data
- Pregnancy, lactation or intention to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Clinical Research Facility
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Human Controlled Infection Study to Establish Safety of Infection With Bordetella Pertussis With Antibiotic Therapy Delayed for up to 6 Weeks
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
Read the detailed description
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.
- Conditions
- Healthy Volunteer Study
- Being tested
- Bordetella pertussis B1917, Azithromycin Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bordetella pertussis B1917Biological
The B. pertussis isolate to be used in this human colonisation model is strain B1917, which is representative of current isolates in Europe. The strain, isolated in 2000 from a Dutch patient with B. pertussis disease, expresses Pertactin (PRN), Pertussis Toxin (PT) and Filamentous Haemagglutinin (FHA). This strain has been extensively characterised in the mouse model as well as by proteomics and transcriptomics and has a closed genome available. It is fully sensitive to azithromycin in vitro.
Azithromycin PillDrug
A 3 day course of azithromycin will be administered to all colonised volunteers at week 6, or sooner if early pertussis disease is suspected
| Study group | Role | What they receive |
|---|---|---|
| Contact | Other | Contact volunteers are those volunteers whose partner/spouse is a Challenge volunteer. Investigators will monitor Contact volunteers to collect information about transmission. A 3 day course of Azithromycin will be administered on week 6 if colonised. Receives: Drug: Azithromycin Pill |
| Challenge | Experimental | Challenge volunteers will receive a nasal inoculation containing Bordetella pertussis on Day 0. They will return to the Clinical Research Facility weekly to monitor safety, colonisation and immune responses. A 3 day course of Azithromycin will be administered on week 6 if colonised. Receives: Biological: Bordetella pertussis B1917; Drug: Azithromycin Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of solicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
- Participants will be asked about the occurrence of solicited adverse events at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested
Measured: 6 weeks.
To assess the incidence of unsolicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
Participants will be asked about the occurrence of unsolicited adverse events at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested
Measured: 6 weeks.
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasal wash.
Bordetella pertussis colonisation will be measured weekly by culture of nasal washes. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
Measured: 6 weeks.
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasopharyngeal swab
Bordetella pertussis colonisation will be measured weekly by culture of nasopharyngeal swabs. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
Measured: 6 weeks.
Secondary outcomes (15)
To establish the change in colonisation density of Bordetella pertussis during prolonged colonisation as measured from nasal wash samples
Bordetella pertussis colonisation density will be measured weekly by culture of nasal washes. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
Measured: 6 weeks.
To establish the change in colonisation density of Bordetella pertussis during prolonged colonisation as measured by nasopharyngeal swab samples
Bordetella pertussis colonisation density will be measured weekly by culture of nasopharyngeal swabs. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
Measured: 6 weeks.
To establish the occurrence of transmission to close contacts during prolonged Bordetella pertussis colonisation
Bordetella pertussis colonisation density will be measured weekly by culture of nasal washes. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
Measured: 6 weeks.
To establish any association between baseline anti-PT IgG level and protection from colonisation with Bordetella pertussis
Anti-PT IgG will be measured in blood at baseline (Day 0)
Measured: Day 0
To establish any association between baseline anti-PRN IgG level and protection from colonisation with Bordetella pertussis
Anti-PRN IgG will be measured in blood at baseline (Day 0)
Measured: Day 0
To establish any association between baseline anti-FHA IgG level and protection from colonisation with Bordetella pertussis
Anti-FHA IgG will be measured in blood at baseline (Day 0)
Measured: Day 0
To establish any association between baseline anti-FIM IgG level and protection from colonisation with Bordetella pertussis
Anti-FIM IgG will be measured in blood at baseline (Day 0)
Measured: Day 0
To monitor change in anti-PT IgG levels during prolonged colonisation with Bordetella pertussis
Anti-PT IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-PRN IgG levels during prolonged colonisation with Bordetella pertussis
Anti-PRN IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-FHA IgG levels during prolonged colonisation with Bordetella pertussis
Anti-FHA IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-FIM IgG levels during prolonged colonisation with Bordetella pertussis
Anti-FIM IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-PT IgG levels associated with natural clearance of Bordetella pertussis
Anti-PT IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-PRN IgG levels associated with natural clearance of Bordetella pertussis
Anti-PRN IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-FHA IgG levels associated with natural clearance of Bordetella pertussis
Anti-FHA IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
To monitor change in anti-FIM IgG levels associated with natural clearance of Bordetella pertussis
Anti-FIM IgG will be measured in blood at standardised timepoints
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start6 Dec 2022
- Primary completion29 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single centre controlled human Bordetella pertussis colonisation study. Intervention: nasal challenge with Bordetella pertussis.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847322
- Sponsor's protocol ID
- IRAS 304211
- Other IDs
- 68737
- Status last verified
- May 2026
- First submitted
- 7 Mar 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Controlled Infection Study to Establish Safety of Infection With Bordetella Pertussis With Antibiotic Therapy Delayed for up to 6 Weeks
- ClinicalTrials.gov ID
- NCT05847322
- Acronym / sponsor ID
- IRAS 304211
- Conditions
- Healthy Volunteer Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre controlled human Bordetella pertussis colonisation study. Intervention: nasal challenge with Bordetella pertussis.
| Arm | Type | Receives |
|---|---|---|
| Contact | Other | Drug: Azithromycin PillContact volunteers are those volunteers whose partner/spouse is a Challenge volunteer. Investigators will monitor Contact volunteers to collect information about transmission. A 3 day course of Azithromycin will be administered on week 6 if colonised. |
| Challenge | Experimental | Biological: Bordetella pertussis B1917, Drug: Azithromycin PillChallenge volunteers will receive a nasal inoculation containing Bordetella pertussis on Day 0. They will return to the Clinical Research Facility weekly to monitor safety, colonisation and immune responses. A 3 day course of Azithromycin will be administered on week 6 if colonised. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (47 listed)
- Individuals living in the same households as:
- Individuals who have inviolable commitments within the study period (from day 0 to week 6 + 2 days) to be in close contact with:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bordetella pertussis B1917The B. pertussis isolate to be used in this human colonisation model is strain B1917, which is representative of current isolates in Europe. The strain, isolated in 2000 from a Dutch patient with B. pertussis disease, expresses Pertactin (PRN), Pertussis Toxin (PT) and Filamentous Haemagglutinin (FHA). This strain has been extensively characterised in the mouse model as well as by proteomics and transcriptomics and has a closed genome available. It is fully sensitive to azithromycin in vitro. | Biological | Challenge |
| Azithromycin PillA 3 day course of azithromycin will be administered to all colonised volunteers at week 6, or sooner if early pertussis disease is suspected | Drug | Challenge, Contact |
Primary outcome
To assess the incidence of solicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
Time frame: 6 weeks.
• Participants will be asked about the occurrence of solicited adverse events at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested
To assess the incidence of unsolicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
Time frame: 6 weeks.
Participants will be asked about the occurrence of unsolicited adverse events at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasal wash.
Time frame: 6 weeks.
Bordetella pertussis colonisation will be measured weekly by culture of nasal washes. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasopharyngeal swab
Time frame: 6 weeks.
Bordetella pertussis colonisation will be measured weekly by culture of nasopharyngeal swabs. Putative positive cultures will be confirmed by polymerase chain reaction (PCR).
15 secondary outcomes
To establish the change in colonisation density of Bordetella pertussis during prolonged colonisation as measured from nasal wash samples
Time frame: 6 weeks.
To establish the change in colonisation density of Bordetella pertussis during prolonged colonisation as measured by nasopharyngeal swab samples
Time frame: 6 weeks.
To establish the occurrence of transmission to close contacts during prolonged Bordetella pertussis colonisation
Time frame: 6 weeks.
To establish any association between baseline anti-PT IgG level and protection from colonisation with Bordetella pertussis
Time frame: Day 0
To establish any association between baseline anti-PRN IgG level and protection from colonisation with Bordetella pertussis
Time frame: Day 0
To establish any association between baseline anti-FHA IgG level and protection from colonisation with Bordetella pertussis
Time frame: Day 0
To establish any association between baseline anti-FIM IgG level and protection from colonisation with Bordetella pertussis
Time frame: Day 0
To monitor change in anti-PT IgG levels during prolonged colonisation with Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-PRN IgG levels during prolonged colonisation with Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-FHA IgG levels during prolonged colonisation with Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-FIM IgG levels during prolonged colonisation with Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-PT IgG levels associated with natural clearance of Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-PRN IgG levels associated with natural clearance of Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-FHA IgG levels associated with natural clearance of Bordetella pertussis
Time frame: 6 weeks.
To monitor change in anti-FIM IgG levels associated with natural clearance of Bordetella pertussis
Time frame: 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bordetella pertussis B1917 and Azithromycin Pill in people with Healthy Volunteer Study, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of solicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers (time frame: 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.