Establishing a Controlled Human Infection Model of Bordetella Pertussis (NCT05136599) | Clinical Trial Compass
CompletedPhase 1
Establishing a Controlled Human Infection Model of Bordetella Pertussis
Canada79 participantsStarted 2022-01-28
Plain-language 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.
Who can participate
Age range18 Years ā 40 Years
SexALL
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Inclusion criteria
ā. Age 18-40 years, inclusive.
ā. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge.
ā. 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).
ā. Written informed consent obtained from the participant.
ā. 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:
ā. Currently fully vaccinated against SARS-CoV-2/COVID-19 according to provincial Public Health guidelines.
ā. If there is a reported history of SARS-CoV-2/COVID-19 infection, the participant must be asymptomatic for \>4 weeks.
Exclusion criteria
ā. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
ā. Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.
What they're measuring
1
Number of participants with mild symptoms of early pertussis disease postchallenge
. 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.
ā. QT prolongation on electrocardiogram (EKG).
ā. History of everyday smoking/vaping in the last 2 years and/or current smoking/vaping more than once per week.
ā. Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding.
ā. 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.