Bordetella pertussis J820 for Whooping Cough

Overseen By Hannah Munday

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Dalhousie University

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

Disqualifiers: Chronic conditions, Cardiac disease, Anxiety, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Bordetella pertussis J820 for whooping cough. The goal is to understand how this treatment works against current strains of the bacteria causing whooping cough. Participants will receive different doses to evaluate their effectiveness and safety. Eligible participants should be in good health and must not have received the whooping cough vaccine in the last 5 years or have a history of whooping cough. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain antibiotics or specific medications like terfenadine, astemizole, theophylline, or cimetidine. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Bordetella pertussis J820 is likely to be safe for humans?

Research has shown that Bordetella pertussis J820 has been tested in animals, such as baboons, and appeared promising without causing severe whooping cough symptoms. The study found it offered some protection against the disease when administered nasally.

Since this treatment is just beginning human trials, limited safety data for people exists. However, its inclusion in a Phase 1 trial indicates some early evidence of potential safety. Phase 1 trials primarily assess a treatment's safety in humans and involve small groups. This suggests that serious side effects are unlikely, but it is only the beginning.

Participants in this trial will help researchers understand how well people tolerate different doses of Bordetella pertussis J820. So far, no severe side effects have been reported, but ongoing trials will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for whooping cough, like antibiotics and vaccines, aim to manage symptoms or prevent the disease. Unlike these standard options, Bordetella pertussis J820 targets the bacteria directly through a novel mechanism, potentially preventing the infection more effectively. Researchers are excited because it might offer a faster and more robust way to protect against whooping cough, especially in populations where traditional vaccines are less effective. Additionally, the study explores different dosing levels, which could optimize its effectiveness and safety profile.

What evidence suggests that Bordetella pertussis J820 might be an effective treatment for whooping cough?

Research has shown that Bordetella pertussis J820 may protect against whooping cough, based on animal studies. Specifically, studies with baboons demonstrated that administering Bordetella pertussis nasally can protect them without causing the usual symptoms of whooping cough. This suggests that the treatment might effectively trigger an immune response to help fight off the infection. Current whooping cough vaccines work well initially, but their protection can decrease over time. Therefore, developing a new method like Bordetella pertussis J820 could provide longer-lasting protection. Participants in this trial will receive different dosages of Bordetella pertussis J820 to evaluate its effectiveness and safety. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can follow the study's procedures, like filling out diary cards and attending follow-up visits. Women at risk of pregnancy must use effective contraception before and after being challenged with B. pertussis.

Inclusion Criteria

I have used birth control for 28 days, tested negative for pregnancy, and will continue using it for 60 days after the study starts.

I've been in good health overall, confirmed by a recent check-up.

I have had both of my fallopian tubes surgically blocked or removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal administration of Bordetella Pertussis to establish a controlled human infection model

4 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lab testing and clinical assessments

4 weeks

Regular visits for clinical assessments and lab testing

Exploratory

Contributing samples to the CDC biorepository

Up to 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bordetella pertussis J820

Trial Overview

The study aims to establish a model using humans infected with a PRN-deficient strain of Bordetella pertussis (J820) to represent strains currently spreading in North America among vaccinated populations.

How Is the Trial Designed?

Group I: Group 5: Dose Number 13 (10^9) Experimental Treatment 1 Intervention

Group II: Group 4: Dose Number 11 (10^8) Experimental Treatment 1 Intervention

Group III: Group 3: Dose Number 9 (10^7) Experimental Treatment 1 Intervention

Group IV: Group 2: Dose Number 7 (10^6) Experimental Treatment 1 Intervention

Group V: Group 1: Dose Number 5 (10^5) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dalhousie University

Lead Sponsor

Trials

177

Recruited

402,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12379594/

Variation in virulence between three representative ...

Intranasal inoculation with Bordetella pertussis confers protection without inducing classical whooping cough in baboons. Curr Res Microb ...

2.

cdc.gov

cdc.gov/pertussis/php/surveillance/index.html

Pertussis Surveillance and Trends | Whooping Cough

View pertussis data, including case counts and incidence by state and age, DTaP vaccination history of cases, and pertussis-related deaths.

3.

journals.asm.org

journals.asm.org/doi/10.1128/spectrum.03527-23

Genome-based prediction of cross-protective, HLA-DR ...

Acellular pertussis vaccines protect against severe pertussis, but vaccine-induced immunity wanes over time. Prior animal studies showed ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5088088/

Effectiveness of pertussis vaccination and duration of immunity

We observed high early effectiveness of the pertussis vaccine that rapidly declined as time since last vaccination surpassed 4 years, particularly with ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8482022/

Pertussis (Whooping Cough) - PMC

Likewise, a study during a pertussis outbreak among Australian high-school students found an effectiveness of 85% (95% CI, 83%–88%) for ...

6.

canada.ca

canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment/bordetella-pertussis.html

Bordetella pertussis: Infectious substances pathogen safety ...

These Pathogen Safety Data Sheets, regulated under Workplace Hazardous Materials Information System (WHMIS) legislation, are produced for ...

7.

cdc.gov

cdc.gov/pertussis/hcp/clinical-overview/index.html

Clinical Overview of Pertussis | Whooping Cough

Some observational studies suggest that pertussis infection can provide immunity for 4 to 20 years, but that it's not lifelong. An image of ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06827470

NCT06827470 | Establishing a Controlled Human Infection ...

Intranasal inoculation of Bordetella pertussis J820 in each naris on Day 1 of the study. What is the study measuring? Primary Outcome Measures ...

9.

ndc.services.cdc.gov

ndc.services.cdc.gov/case-definitions/pertussis-2020/

Pertussis (Whooping Cough) (Bordetella pertussis) 2020 ...

Bordetella pertussis is among the most poorly controlled bacterial vaccine-preventable diseases in the U.S. Pertussis vaccine was introduced in ...