Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
ConditionPertussis (Whooping Cough)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorDalhousie University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Biological: Bordetella pertussis J820
Treatment groups
60 Participants
are divided into 5 treatment groupsSponsors and collaborators
Dalhousie University
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov