Scientists deliberately infect volunteers with whooping cough to speed up vaccine research

NCT ID NCT06827470

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a safe, controlled human infection model for whooping cough. Healthy adults aged 18-50 will receive a nasal dose of the bacteria to cause a mild infection. Researchers will monitor symptoms and test nasal samples to find the best dose that infects most people safely. This model will help test future vaccines and treatments more efficiently.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be eligible for the study, each participant must satisfy ALL of the following criteria: 1. Age 18-50 years, inclusive. 2. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge. 3. 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). 4. Written informed consent obtained from the participant. 5. 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. 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 Exclusion Criteria: Participants with ANY of the following criteria at the time of screening will be excluded: 1. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder). 2. Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis. 3. 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. 4. QT prolongation on electrocardiogram (EKG). 5. History of everyday smoking/vaping in the last 2 years and/or current smoking/vaping more than once per week. 6. Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding. 7. 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. 8. Positive for hepatitis B or C by blood test. 9. Vaccinated against pertussis within previous 5 years and/or \>7 cumulative doses from infancy to date of screening. 10. Reported history of laboratory-confirmed pertussis infection, including having been exposed to B. pertussis in a Controlled Human Infection Model 11. Antibody titer to pertussis toxin \>20 IU/mL (2x the lower limit of quantification (LLOQ)). 12. Detection of B. pertussis in nasal samples prior to challenge using culture isolation and/or PCR detection, or detection of other respiratory infection. 13. 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. 14. Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months. 15. Any contraindication to receiving azithromycin. 16. Taking any systemic antibiotic currently or within the previous 2 weeks. 17. Currently taking terfenadine, astemizole, theophylline, or cimetidine. 18. Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts. 19. Recent (within 6 months) nasal or sinus surgery, recent use of intranasal steroids (4 weeks), or diagnosis with nasal polyps. 20. 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. 21. 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.) 22. Previous moderate or severe respiratory infection that required hospitalization. 23. Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening. 24. Any other finding that the Investigator considers will make the participant unsuitable for the study or unable to comply with the study requirements. 25. 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. 26. History of Bell's Palsy and/or facial paralysis. 27. Receipt of facial cosmetic filler in the past 3 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Canadian Center for Vaccinology

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.