Pertussis (Whooping Cough)Phase 1NCT06827470
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
A Phase 1 study testing Biological: Bordetella pertussis J820 in people with Pertussis (Whooping Cough), run by Dalhousie University at 1 site in Canada.
Trial summary
The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis (Whooping Cough)
- What is being tested?
- Biological: Bordetella pertussis J820
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2025to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for the study, each participant must satisfy ALL of the following criteria:
- Age 18-50 years, inclusive.
- Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge.
- Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., complete Diary Cards, return for follow-up visits).
- Written informed consent obtained from the participant.
- If a cis woman and/or gender divergent person is at risk of becoming pregnant has practiced adequate contraception for 28 days prior to challenge and has a negative pregnancy test on the day before B. pertussis challenge and has agreed to continue adequate contraception until 60 days after inoculation.
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- Risk of pregnancy is defined as any individual assigned female at birth or with reproductive capacity who is sexually active with individuals with sperm-producing capabilities. Individuals who have received the following are considered to not have reproductive capacity:
- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Documented and current bilateral tubal ligation or occlusion
- Credible self-reported history of diagnosed infertility
- Hormone therapy (e.g., testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased
- Any other condition, as determined by the Principal Investigator, that would render an individual incapable of becoming pregnant
- Adequate contraception is defined as a contraceptive method with a failure rate of <1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
- Intra-uterine device (IUD) with or without hormonal release
- Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success
- Credible self-reported history of abstinence for at least 28 days prior to challenge
Who cannot join
- Participants with ANY of the following criteria at the time of screening will be excluded:
- Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
- Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.
- Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use, or eating disorder.
- QT prolongation on electrocardiogram (EKG).
- History of everyday smoking/vaping in the last 2 years and/or current smoking/vaping more than once per week.
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- Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding.
- Immunocompromised (with HIV/AIDS-positive or receiving immunosuppressive therapy involving steroids) or with any medical condition or medication that leads to a compromised immune system.
- Positive for hepatitis B or C by blood test.
- Vaccinated against pertussis within previous 5 years and/or >7 cumulative doses from infancy to date of screening.
- Reported history of laboratory-confirmed pertussis infection, including having been exposed to B. pertussis in a Controlled Human Infection Model
- Antibody titer to pertussis toxin >20 IU/mL (2x the lower limit of quantification (LLOQ)).
- Detection of B. pertussis in nasal samples prior to challenge using culture isolation and/or PCR detection, or detection of other respiratory infection.
- Living or working with (any form of close contact) any of the at-risk/vulnerable groups who are not up to date on their vaccination, specifically children <1 year of age, pregnant woman who have not yet received their maternal Tdap vaccine, immunocompromised individuals, adults >65 years of age who have not received a dose of Tdap vaccine within the past 10 years, or other at risk persons, as applicable, up to Day 57.
- Note: Household members whose vaccination is not current will be offered or directed to a pertussis-containing vaccine, as recommended and funded by the Nova Scotia Department of Health and Wellness.
- Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months.
- Any contraindication to receiving azithromycin.
- Taking any systemic antibiotic currently or within the previous 2 weeks.
- Currently taking terfenadine, astemizole, theophylline, or cimetidine.
- Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts.
- Recent (within 6 months) nasal or sinus surgery, recent use of intranasal steroids (4 weeks), or diagnosis with nasal polyps.
- Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational vaccine is defined as a vaccine that is still being tested in clinical trials or one that has not yet been authorized for use in Canada for administration by public vaccine programs.
- Receipt of any authorized vaccines within 2 weeks prior to challenge with B. pertussis in this study. (This is to avoid attributing any AEs from these vaccines to the B. pertussis challenge, which would skew the study results.)
- Previous moderate or severe respiratory infection that required hospitalization.
- Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.
- Any other finding that the Investigator considers will make the participant unsuitable for the study or unable to comply with the study requirements.
- Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Day -1 (check-in) or Study Day 1 before a participant is challenged.
- History of Bell's Palsy and/or facial paralysis.
- Receipt of facial cosmetic filler in the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: Open-label, Phase 1/2, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining and Confirming the Optimal and Safe J820 Bordetella Pertussis Dose Administered Intranasally to Healthy Adults 18-50 Years of Age That Induces Mild Symptomatic Infection and Detection of B. Pertussis in Nasal Samples
The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.
- Conditions
- Pertussis (Whooping Cough)
- Being tested
- Biological: Bordetella pertussis J820
- Keywords
- Bordetella pertussis, Pertussis, Whooping cough, Controlled human infection model, Human challenge, Phase 1 clinical trial, Immune response
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Bordetella pertussis J820Biological
Intranasal inoculation of Bordetella pertussis J820 in each naris on Day 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dose Number 5 (10^5) | Experimental | Not described Receives: Biological: Biological: Bordetella pertussis J820 |
| Group 2: Dose Number 7 (10^6) | Experimental | Not described Receives: Biological: Biological: Bordetella pertussis J820 |
| Group 3: Dose Number 9 (10^7) | Experimental | Not described Receives: Biological: Biological: Bordetella pertussis J820 |
| Group 4: Dose Number 11 (10^8) | Experimental | Not described Receives: Biological: Biological: Bordetella pertussis J820 |
| Group 5: Dose Number 13 (10^9) | Experimental | Not described Receives: Biological: Biological: Bordetella pertussis J820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures
Establish a PRN-deficient pertussis CHIM that identifies the lowest challenge dose that successfully \& safely infects nearly all (≥85%) participants challenged (HID) \& produces the highest achievable rate of symptomatic infection (HSD), including cough, using an adaptive dose response design.
This is contingent upon determining each participant's clinical outcome post-challenge to compute the rate of symptomatic infection \& rate of overall infection per dose group, based on outcomes for all participants receiving that dose. As a derived variable, clinical outcomes will be measured/determined using programmed case definitions previously designed to emulate the natural course of early pertussis disease following experimentally induced pertussis infection. Clinical outcome measures include:
- B. pertussis lab testing of samples (culture, PCR, serology)
- Clinical assessments (safety bloods, physical exams, DCs, symptom self-reporting).
Measured: Study Day 1 up to Study Day 29
Secondary outcomes (5)
Secondary Outcome Measures
- To measure the rate of cough and describe the clinical presentation via:
- Self-reporting
- Clinical assessment
Measured: Study Day 1 up to Study Day 29
Secondary Outcome Measures
- To evaluate the immune response following challenge associated with infection via:
- Humoral immune responses (analyte; unit; sample; technique):
- Anti-PT Antibodies; IU/mL; Serum; ELISA B) Anti-FHA Antibodies; IU/mL; Serum; ELISA C) Anti-PRN Antibodies; IU/mL; Serum; ELISA D) Anti-FIM Antibodies; EU/mL; Serum; ELISA
Measured: Day 1 up to Study Day 181
Secondary Outcome Measure
- To evaluate the immune response following challenge associated with infection via:
- Cellular \& Cellular-mediated immune responses
Cellular:
- Eotaxin-2, Perfornin, Granzyme-A \& Granzyme-B; all pg/mL, by nasal wash using Luminex
Cellular-mediated:
- Neutrophil CD16+, B cell CD19+, T Cell CD4+, T cells CD8+, Mucosal associated invariant T cell(MAIT) cells, NK cell CD3-CD56+, Monocyte CD14+, Eosinophil Siglec8+, gamma delta T cell; all % \& absolute count, by whole blood \& nasal swab using Flow cytometry
Measured: Time Frame: Day 1 up to Study Day 181
Secondary Outcome Measures
- To explore the time course of azithromycin therapy in clearing infection and/or symptoms, via testing during treatment as applicable via:
- B. pertussis laboratory testing of samples (culture, PCR): A) The mean number of days to culture negativity (i.e., bacterial count of zero in both NW and NPA samples) in days (with a 95% confidence interval) following treatment.
- The mean number of days to PCR negativity (i.e., PCR negative for each of the targets, that is IS481 and ptxS1 in both NW and NPA samples in days (with a 95% CI) following treatment.
- The cumulative proportion of participants that are negative by day following treatment by culture and PCR.
Measured: Study Day 1 up to Study Day 29
Secondary Outcome Measure
- To explore the time course of azithromycin therapy in clearing infection and/or symptoms, via testing during treatment as applicable via:
- Clinical assessments (as needed): A) The mean number of days to symptom resolution (i.e., no reporting/detection of symptoms and/or signs) in days (with a 95% confidence interval) following treatment.
- The cumulative proportion of participants with resolved pertussis symptoms by day following treatment.
Measured: Time Frame: Study Day 1 up to Study Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start24 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis (Whooping Cough)Studies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827470
- Sponsor's protocol ID
- CD2301
- Other IDs
- 75D30123C17596
- Status last verified
- Nov 2025
- First submitted
- 14 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase 1/2, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining and Confirming the Optimal and Safe J820 Bordetella Pertussis Dose Administered Intranasally to Healthy Adults 18-50 Years of Age That Induces Mild Symptomatic Infection and Detection of B. Pertussis in Nasal Samples
- ClinicalTrials.gov ID
- NCT06827470
- Acronym / sponsor ID
- CD2301
- Conditions
- Pertussis (Whooping Cough)
- Keywords
- Bordetella pertussis, Pertussis, Whooping cough, Controlled human infection model, Human challenge, Phase 1 clinical trial, Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dose Number 5 (10^5) | Experimental | Biological: Biological: Bordetella pertussis J820 |
| Group 2: Dose Number 7 (10^6) | Experimental | Biological: Biological: Bordetella pertussis J820 |
| Group 3: Dose Number 9 (10^7) | Experimental | Biological: Biological: Bordetella pertussis J820 |
| Group 4: Dose Number 11 (10^8) | Experimental | Biological: Biological: Bordetella pertussis J820 |
| Group 5: Dose Number 13 (10^9) | Experimental | Biological: Biological: Bordetella pertussis J820 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- To be eligible for the study, each participant must satisfy ALL of the following criteria:
- Age 18-50 years, inclusive.
- Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge.
- Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., complete Diary Cards, return for follow-up visits).
- Written informed consent obtained from the participant.
Key exclusion criteria (29 listed)
- Participants with ANY of the following criteria at the time of screening will be excluded:
- Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
- Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.
- Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use, or eating disorder.
- QT prolongation on electrocardiogram (EKG).
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 |
|---|---|---|
| Biological: Bordetella pertussis J820Intranasal inoculation of Bordetella pertussis J820 in each naris on Day 1 of the study. | Biological | Group 1: Dose Number 5 (10^5), Group 2: Dose Number 7 (10^6), Group 3: Dose Number 9 (10^7), Group 4: Dose Number 11 (10^8), Group 5: Dose Number 13 (10^9) |
Primary outcome
Primary Outcome Measures
Time frame: Study Day 1 up to Study Day 29
Establish a PRN-deficient pertussis CHIM that identifies the lowest challenge dose that successfully \& safely infects nearly all (≥85%) participants challenged (HID) \& produces the highest achievable rate of symptomatic infection (HSD), including cough, using an adaptive dose response design. This is contingent upon determining each participant's clinical outcome post-challenge to compute the rate of symptomatic infection \& rate of overall infection per dose group, based on outcomes for all participants receiving that dose. As a derived variable, clinical outcomes will be measured/determined using programmed case definitions previously designed to emulate the natural course of early pertussis disease following experimentally induced pertussis infection. Clinical outcome measures include: 1. B. pertussis lab testing of samples (culture, PCR, serology) 2. Clinical assessments (safety bloods, physical exams, DCs, symptom self-reporting).
5 secondary outcomes
Secondary Outcome Measures
Time frame: Study Day 1 up to Study Day 29
Secondary Outcome Measures
Time frame: Day 1 up to Study Day 181
Secondary Outcome Measure
Time frame: Time Frame: Day 1 up to Study Day 181
Secondary Outcome Measures
Time frame: Study Day 1 up to Study Day 29
Secondary Outcome Measure
Time frame: Time Frame: Study Day 1 up to Study Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological: Bordetella pertussis J820 in people with Pertussis (Whooping Cough), run by Dalhousie University at 1 site in Canada.
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 20 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nick Bartlett (902-470-8141, nicholas.bartlett@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures (time frame: Study Day 1 up to Study Day 29). 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 4 Dec 2025.