Actively Recruiting
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
Led by Dalhousie University · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
D
Dalhousie University
Lead Sponsor
C
Centers for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years inclusive
- Good general health based on recent medical history and physical exam
- Ability and willingness to follow study requirements, including diary completion and follow-up visits
- Provided written informed consent
- For cis women and gender-diverse persons at risk of pregnancy: use of adequate contraception for 28 days before challenge, negative pregnancy test before inoculation, and agreement to continue contraception for 60 days after
You will not qualify if you...
- Chronic medical conditions needing ongoing doctor care (e.g., diabetes, seizures)
- Heart or lung disease including hypertension, angina, asthma, emphysema, chronic bronchitis, or tuberculosis
- Moderate or severe anxiety, mood disorders, or major psychiatric illnesses
- QT prolongation on EKG
- Smoking or vaping daily in last 2 years or more than once per week currently
- Pregnant or breastfeeding
- Immunocompromised or on immunosuppressive therapy
- Positive hepatitis B or C blood test
- Vaccinated against pertussis within 5 years or more than 7 doses total
- History of laboratory-confirmed pertussis infection or prior B. pertussis challenge
- High antibody levels to pertussis toxin
- Detection of B. pertussis or other respiratory infection before challenge
- Living or working with at-risk unvaccinated individuals up to Day 57
- Allergy to macrolides or recent C. difficile infection
- Contraindication to azithromycin
- Recent or current antibiotic use
- Taking certain medications (terfenadine, astemizole, theophylline, cimetidine)
- Poor venous access
- Recent nasal/sinus surgery, steroid use, or nasal polyps
- Recent participation in investigational drug or vaccine studies
- Recent vaccination within 2 weeks
- Prior moderate/severe respiratory infection needing hospitalization
- Recent head trauma
- History of Bell's Palsy or facial paralysis
- Recent facial cosmetic filler use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
Research Team
N
Nick Bartlett
CONTACT
H
Hannah Munday
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here