PertussisPhase 1NCT05136599
Establishing a Controlled Human Infection Model of Bordetella Pertussis
A Phase 1 study testing Bordetella pertussis D420 in people with Pertussis, run by Dalhousie University at 1 site in Canada.
Trial summary
This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Bordetella pertussis D420
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2022to 14 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 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 18-40 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 female of childbearing potential and heterosexually active, 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. 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:
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- 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, provided that this is the participant's sole partner and that he has received a medical assessment of the surgical success
- Credible self-reported history of heterosexual abstinence for at least 28 days prior to challenge
- Female partner
- A premenopausal woman who has at least one of the following is considered not of childbearing potential:
- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Documented and current bilateral tubal ligation or occlusion
- Currently fully vaccinated against SARS-CoV-2/COVID-19 according to provincial Public Health guidelines.
- If there is a reported history of SARS-CoV-2/COVID-19 infection, the participant must be asymptomatic for >4 weeks.
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.
Show all 29Show fewer
- 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.
- 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.
- Antibody titer to pertussis toxin >20 EU/mL (2x the lower limit of quantification (LLOQ)).
- Nasopharyngeal detection of B. pertussis prior to challenge using culture isolation and/or PCR detection, or detection of other respiratory infection.
- Living with young children (<1 year of age) or with any household member not current in their pertussis immunization up to Day 56 post-challenge. Note: Household members whose vaccination is not current will be offered a pertussis-containing vaccine, as recommended and funded by the Nova Scotia Department of Health and Wellness.
- Living or working with (any form of close contact) any of the at-risk/vulnerable groups (children <1 year of age, pregnant woman who have not yet received their maternal Tdap vaccine, immunocompromised individuals, anyone not current in their pertussis immunization, or adults >65 years of age who have not received a dose of Tdap vaccine within the past 10 years) up to Day 56 post-challenge.
- Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months.
- Any contraindication to receiving azithromycin.
- Taking any antibiotic currently or within the previous 2 weeks.
- Currently taking terfenadine, astemizole, theophylline, or cimetidine.
- 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 (including SARS-CoV-2/COVID-19 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 of being challenged 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.)
- Current laboratory-confirmed SARS-CoV-2/COVID-19 infection.
- Previous moderate or severe laboratory-confirmed SARS-CoV-2/COVID-19 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 Day 0 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.
About this study
Official title: Open-label, Phase 1, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining the Optimal and Safe Bordetella Pertussis Dose That Induces Mild Symptomatic Infection and Colonization in Healthy Adults
This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults.
Read the detailed description
This is a single-center trial to develop a Bordetella pertussis Controlled Human Infection Model (CHIM) using a two-study approach: the first study is a human infectious dose 70%-90% (HID70-90) identification study, and the second an HID70-90 dose confirmation study to verify and confirm that the infectious endpoint has been reached. The infectious endpoint is positive nasopharyngeal culture(s) and/or polymerase chain reaction(s) (PCR(s)) for B. pertussis with concurrent or subsequent development of mild pertussis disease symptoms such as rhinorrhea and cough within the 16-day inpatient period following challenge.
The trial is an open-label, phase 1, dose escalation, self-contained trial; participants will be allocated to challenge dose groups to receive a single intranasal dose of challenge inoculum. All participants will receive a 5-day course of azithromycin eradication therapy either 24-48 hours after they develop symptoms or at the end of the 16-day postchallenge observation period.
The optimal/target inoculum is one that induces mild symptomatic infection and detection of B. pertussis in nasopharyngeal cultures in 70%-90% of participants receiving it, to establish a safe and reproducible pertussis CHIM.
Safety monitoring includes close clinical observation during a 16-21-day inpatient postchallenge period in the Canadian Center for Vaccinology's Challenge Unit, a Data and Safety Monitoring Board, and participant Diary Cards.
- Conditions
- Pertussis
- Being tested
- Bordetella pertussis D420
- 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.
Bordetella pertussis D420Biological
Intranasal inoculation of Bordetella pertussis D420 in each naris on Day 0 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Dose #3 | Experimental | Challenge dose of 10^4 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #5 | Experimental | Challenge dose of 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #6 | Experimental | Challenge dose of 5 x 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #7 | Experimental | Challenge dose of 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #8 | Experimental | Challenge dose of 5 x 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #9 | Experimental | Challenge dose of 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #10 | Experimental | Challenge dose of 5 x 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
| Dose #11 | Experimental | Challenge dose of 10^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris) Receives: Biological: Bordetella pertussis D420 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pertussis Infection With Mild Symptoms of Early Pertussis Disease Postchallenge
Mild, Grade 1, symptoms of pertussis are symptoms that do not interfere with everyday activities. They may include malaise, rhinorrhea, sneezing and/or lacrimation, low-grade fever, or cough.
Measured: Day 7 to treatment
Secondary outcomes (1)
Number of Participants Who Demonstrate Shedding of Bordetella Pertussis Postchallenge as Determined by Positive Culture and/or PCR Test of Nasopharyngeal Samples
The presence of B. pertussis is detected by positive culture (i.e., presence of any B. pertussis colonies) of nasopharyngeal samples. It is also detected by three or more positive PCR (polymerase chain reaction) tests of nasopharyngeal samples. Both methods are used in this study; a positive result in either culture and/or PCR test demonstrates shedding of B. pertussis.
Measured: Day 7 to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start28 Jan 2022
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies 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
- Model description
- The clinical trial will be conducted as two dependent studies. The first study is a dose identification study to determine the HID70-90 endpoint, which is the dose that induces pertussis mild symptomatic/clinical infection among 70%-90% of the volunteers inoculated with that dose. The second study and sub-study are HID70-90 dose confirmation studies to verify and confirm that the infectious endpoint has been reached to establish the pertussis CHIM.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention, Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Scott A. Halperin, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136599
- Sponsor's protocol ID
- CD2001
- Other IDs
- R34AI148056, 75D30120C08608
- Status last verified
- Jun 2024
- First submitted
- 2 Nov 2021
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ElSherif MS, Redden KL, Langley JM, Ye L, Blanchard W, Smith B, Wang J, Abu-Raya B, Filliter JH, Edwards KM, Creech CB, McNeil S, Hatchette TF, LeBlanc JJ, Hariri S, Pawloski L, Maniatis P, Fox LM, Whittle CA, Halperin SA. A controlled human infection model for symptomatic pertussis in North America using the pertactin-producing clinical isolate D420. medRxiv [Preprint]. 2026 Jun 15:2026.06.09.26355227. doi: 10.64898/2026.06.09.26355227.
PubMed 42369467
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase 1, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining the Optimal and Safe Bordetella Pertussis Dose That Induces Mild Symptomatic Infection and Colonization in Healthy Adults
- ClinicalTrials.gov ID
- NCT05136599
- Acronym / sponsor ID
- CD2001
- Conditions
- Pertussis
- 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
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention, Vanderbilt University Medical Center
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults.
Detailed description
This is a single-center trial to develop a Bordetella pertussis Controlled Human Infection Model (CHIM) using a two-study approach: the first study is a human infectious dose 70%-90% (HID70-90) identification study, and the second an HID70-90 dose confirmation study to verify and confirm that the infectious endpoint has been reached. The infectious endpoint is positive nasopharyngeal culture(s) and/or polymerase chain reaction(s) (PCR(s)) for B. pertussis with concurrent or subsequent development of mild pertussis disease symptoms such as rhinorrhea and cough within the 16-day inpatient period following challenge.
The trial is an open-label, phase 1, dose escalation, self-contained trial; participants will be allocated to challenge dose groups to receive a single intranasal dose of challenge inoculum. All participants will receive a 5-day course of azithromycin eradication therapy either 24-48 hours after they develop symptoms or at the end of the 16-day postchallenge observation period.
The optimal/target inoculum is one that induces mild symptomatic infection and detection of B. pertussis in nasopharyngeal cultures in 70%-90% of participants receiving it, to establish a safe and reproducible pertussis CHIM.
Safety monitoring includes close clinical observation during a 16-21-day inpatient postchallenge period in the Canadian Center for Vaccinology's Challenge Unit, a Data and Safety Monitoring Board, and participant Diary Cards.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The clinical trial will be conducted as two dependent studies. The first study is a dose identification study to determine the HID70-90 endpoint, which is the dose that induces pertussis mild symptomatic/clinical infection among 70%-90% of the volunteers inoculated with that dose. The second study and sub-study are HID70-90 dose confirmation studies to verify and confirm that the infectious endpoint has been reached to establish the pertussis CHIM.
| Arm | Type | Receives |
|---|---|---|
| Dose #3 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 10^4 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #5 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #6 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 5 x 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #7 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #8 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 5 x 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #9 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #10 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 5 x 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
| Dose #11 | Experimental | Biological: Bordetella pertussis D420Challenge dose of 10^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- To be eligible for the study, each participant must satisfy ALL of the following criteria:
- Age 18-40 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 |
|---|---|---|
| Bordetella pertussis D420Intranasal inoculation of Bordetella pertussis D420 in each naris on Day 0 of the study. | Biological | Dose #10, Dose #11, Dose #3, Dose #5, Dose #6, Dose #7, Dose #8, Dose #9 |
Primary outcome
Number of Participants With Pertussis Infection With Mild Symptoms of Early Pertussis Disease Postchallenge
Time frame: Day 7 to treatment
Mild, Grade 1, symptoms of pertussis are symptoms that do not interfere with everyday activities. They may include malaise, rhinorrhea, sneezing and/or lacrimation, low-grade fever, or cough.
1 secondary outcome
Number of Participants Who Demonstrate Shedding of Bordetella Pertussis Postchallenge as Determined by Positive Culture and/or PCR Test of Nasopharyngeal Samples
Time frame: Day 7 to treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42369467ElSherif MS, Redden KL, Langley JM, Ye L, Blanchard W, Smith B, Wang J, Abu-Raya B, Filliter JH, Edwards KM, Creech CB, McNeil S, Hatchette TF, LeBlanc JJ, Hariri S, Pawloski L, Maniatis P, Fox LM, Whittle CA, Halperin SA. A controlled human infection model for symptomatic pertussis in North America using the pertactin-producing clinical isolate D420. medRxiv [Preprint]. 2026 Jun 15:2026.06.09.26355227. doi: 10.64898/2026.06.09.26355227.
- Canadian Center for Vaccinology Challenge Unit home pageLink provided by the sponsor.
- Canadian Center for Vaccinology home pageLink provided by the sponsor.
- 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.
Scott A. Halperin, MD principal investigator
Dalhousie University
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 Bordetella pertussis D420 in people with Pertussis, 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 19 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: finished, as of the sponsor's last update on 3 Sep 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 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?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Pertussis Infection With Mild Symptoms of Early Pertussis Disease Postchallenge (time frame: Day 7 to treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136599, which also lists 1 linked publication.
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 3 Sep 2026.