Bordetella pertussis J820 for Whooping Cough
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.
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.12345Why 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.36789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal administration of Bordetella Pertussis to establish a controlled human infection model
Follow-up
Participants are monitored for safety and effectiveness after treatment, including lab testing and clinical assessments
Exploratory
Contributing samples to the CDC biorepository
What Are the Treatments Tested in This Trial?
Interventions
- Bordetella pertussis J820
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dalhousie University
Lead Sponsor
Centers for Disease Control and Prevention
Collaborator