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Completed
NCT05136599
Establishing a Controlled Human Infection Model of Bordetella Pertussis
Conditions: Pertussis
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 79
Sponsor: Dalhousie University
Location: Canadian Center for Vaccinology Halifax Nova Scotia
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.
Eligibility Criteria
Inclusion Criteria:
To be eligible for the study, each participant must satisfy ALL of the following criteria:
1. Age 18-40 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 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 \
Source: ClinicalTrials.gov (NCT05136599). StuddyBuddy aggregates publicly available trial information.