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Bordetella Pertussis Infection Model for Whooping Cough

Phase 1
Recruiting
Led By Scott A. Halperin, MD
Research Sponsored by Dalhousie University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-40 years, inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 14
Awards & highlights

Study Summary

This trial is testing how much of a specific bacteria is needed to make a healthy adult mildly sick.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include mild whooping cough symptoms such as coughing fits, difficulty breathing, and fatigue due to B. pertussis colonization. Since this is an initial model establishment study, other unexpected side effects related to immune response might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with mild symptoms of early pertussis disease postchallenge
Secondary outcome measures
Number of participants who demonstrate shedding of Bordetella pertussis postchallenge as determined by positive culture and/or PCR test of nasopharyngeal samples

Trial Design

10Treatment groups
Experimental Treatment
Group I: Study 1 (Dose-identification study), Dose 9Experimental Treatment1 Intervention
Challenge dose of 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group II: Study 1 (Dose-identification study), Dose 8Experimental Treatment1 Intervention
Challenge dose of 5 x 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group III: Study 1 (Dose-identification study), Dose 7Experimental Treatment1 Intervention
Challenge dose of 10^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group IV: Study 1 (Dose-identification study), Dose 6Experimental Treatment1 Intervention
Challenge dose of 5 x 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group V: Study 1 (Dose-identification study), Dose 5Experimental Treatment1 Intervention
Challenge dose of 10^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group VI: Study 1 (Dose-identification study), Dose 4Experimental Treatment1 Intervention
Challenge dose of 5 x 10^4 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group VII: Study 1 (Dose-identification study), Dose 3Experimental Treatment1 Intervention
Challenge dose of 10^4 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group VIII: Study 1 (Dose-identification study), Dose 2Experimental Treatment1 Intervention
Challenge dose of 5 x 10^3 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group IX: Study 1 (Dose-identification study), Dose 10Experimental Treatment1 Intervention
Challenge dose of 5 x 10^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
Group X: Study 1 (Dose-identification study), Dose 1Experimental Treatment1 Intervention
Challenge dose of 10^3 cfu B. pertussis in 0.2 mL (0.1 mL per naris)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

IntravaccIndustry Sponsor
Dalhousie UniversityLead Sponsor
167 Previous Clinical Trials
403,072 Total Patients Enrolled
1 Trials studying Whooping Cough
10 Patients Enrolled for Whooping Cough
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,403 Total Patients Enrolled
6 Trials studying Whooping Cough
23,735 Patients Enrolled for Whooping Cough

Media Library

Bordetella pertussis D420 2023 Treatment Timeline for Medical Study. Trial Name: NCT05136599 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research encompass subjects over 50 years of age?

"The age range for potential participants in this research is between 18 and 40 years old."

Answered by AI

Is it possible for me to join this research experiment?

"This medical trial is recruiting 66 individuals aged 18-40 years old with pertussis. Among the criteria for enrollment are sound physical health, agreement to follow protocol guidelines, written informed consent and use of contraception such as oral or transdermal hormonal contraceptives, progestogen-only methods (oral/injectable/implant), intrauterine device with or without hormone release, vasectomized partner with proof of surgical success, credible self-reported history of heterosexual abstinence in the last 28 days prior to challenge and a female partner."

Answered by AI

Is there room for more participants in this experiment?

"Deductions from clinicaltrials.gov reveal that this medical study is not currently enrolling patients, having last been updated on November 15th 2021 since it was first posted January 17th 2022. Nevertheless, there are 783 other studies in the same field presently recruiting participants."

Answered by AI

Can you explain the risk factors associated with administering Bordetella pertussis D420 to patients?

"Due to the limited data that supports its safety and efficacy, Bordetella pertussis D420 was scored a 1 on our organization's risk assessment scale."

Answered by AI

How many individuals have participated in this experiment thus far?

"Currently, no new participants are being recruited for this trial. Initially posted on January 17th 2022 and last updated on November 15th 2021, it is now inactive. However, there exist 776 other trials actively enrolling patients with pertussis and an additional seven studies recruiting subjects suffering from Bordetella Pertussis D420."

Answered by AI

Could you provide further particulars regarding experiments that have included the use of Bordetella pertussis D420?

"Currently, there is 1 Phase 3 trial for Bordetella pertussis D420 with 7 total studies in operation. While Halifax, Nova Scotia hosts the majority of these trials, 57 locations are actively participating."

Answered by AI

Is this research groundbreaking within its field?

"Since its initial Phase 2 trial in 2016, supported by Pharmacyclics LLC., there have been 38 studies conducted on Bordetella pertussis D420 across 42 cities and 6 countries. At present, 7 active trials are ongoing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Establishing a Controlled Human Infection Model of Bordetella Pertussis
2022. "Establishing a Controlled Human Infection Model of Bordetella Pertussis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136599.
~21 spots leftby Apr 2025
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