Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis (NCT06827470) | Clinical Trial Compass
RecruitingPhase 1
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
Canada60 participantsStarted 2025-11-24
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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.
. History of everyday smoking/vaping in the last 2 years and/or current smoking/vaping more than once per week.
✕. 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.