Bordetella Pertussis Infection Model for Whooping Cough

Overseen By Kylie Peacock

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Dalhousie University

Must not be taking: Antibiotics, Terfenadine, Astemizole, others

Disqualifiers: Chronic conditions, Cardiac/pulmonary disease, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

79 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Scott A. Halperin, MD

Principal Investigator

Dalhousie University

Eligibility Criteria

Healthy adults aged 18-40 who can follow the study's protocol. Women must use contraception and have a negative pregnancy test before the challenge. Excluded are pregnant or breastfeeding women, those with recent nasal surgery or respiratory infections, certain medication users, people living with young children or immunocompromised individuals, smokers/vapers, and anyone with a history of pertussis infection or vaccination against it within the last five years.

Inclusion Criteria

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

I am a premenopausal woman with certain surgical procedures done or fully vaccinated against COVID-19.

Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge

Exclusion Criteria

My immune system is weakened due to a condition or medication.

I have smoked or vaped almost every day in the past 2 years.

Your heart's electrical activity is abnormal on an EKG.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Challenge and Observation

Participants receive a single intranasal dose of challenge inoculum and are observed for mild symptomatic infection and colonization

16-21 days

Inpatient stay

Treatment

Participants receive a 5-day course of azithromycin eradication therapy either 24-48 hours after symptom development or at the end of the observation period

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bordetella pertussis D420

Trial Overview The trial is testing Bordetella pertussis D420 to establish a safe dose that causes mild symptoms in healthy adults without causing serious illness. Participants will be monitored for colonization and symptomatic infection after receiving this bacterial challenge.

Participant Groups

Group I: Sub-Study (Dose confirmation study), Cohort 11, Dose #11 Experimental Treatment 1 Intervention

Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group II: Study 2 (Dose confirmation study), Cohort 9, Dose #9 Experimental Treatment 1 Intervention

Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group III: Study 2 (Dose confirmation study), Cohort 9, Dose #10 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group IV: Study 2 (Dose confirmation study), Cohort 8, Dose #9 Experimental Treatment 1 Intervention

Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group V: Study 2 (Dose confirmation study), Cohort 8, Dose #10 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group VI: Study 2 (Dose confirmation study), Cohort 11, Dose #10 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group VII: Study 2 (Dose confirmation study), Cohort 10, Dose #8 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group VIII: Study 1 (Dose-identification study), Cohort 7, Dose #9 Repeat Experimental Treatment 1 Intervention

Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group IX: Study 1 (Dose-identification study), Cohort 6, Dose #9 Experimental Treatment 1 Intervention

Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group X: Study 1 (Dose-identification study), Cohort 5, Dose #8 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group XI: Study 1 (Dose-identification study), Cohort 4, Dose #7 Experimental Treatment 1 Intervention

Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group XII: Study 1 (Dose-identification study), Cohort 3, Dose #6 Experimental Treatment 1 Intervention

Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group XIII: Study 1 (Dose-identification study), Cohort 2, Dose #5 Experimental Treatment 1 Intervention

Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)

Group XIV: Study 1 (Dose-identification study), Cohort 1, Dose #3 Experimental Treatment 1 Intervention

Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)

Who Is Running the Clinical Trial?

Dalhousie University

Lead Sponsor

Trials

177

Recruited

402,000+

Intravacc

Industry Sponsor

Trials

1

Recruited

80+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+