Establishing a Controlled Human Infection Model of Bordetella pertussis

Enrollment for this study is now CLOSED. Thank you for your interest!

A challenge to make a difference.

Current pertussis (whooping cough) vaccines have reduced case numbers, but the disease is still common and can be fatal for infants. As a first step towards developing a more effective vaccine, CCfV is conducting a human challenge trial in Halifax to study how the disease progresses. You may be able to help.

If you’re 18-40 and in good health, you can

Sign up

What is a human challenge trial?

Also known as controlled human infection models, human challenge trials are a type of clinical trial that intentionally exposes healthy, informed, and consenting adult volunteers to a virus or bacteria. This is done in a safe environment that prevents the spread of the illness and with around-the-clock healthcare support.

Challenge studies may either vaccinate participants to test a specific vaccine or simply expose participants to an infection to help researchers learn more about how an illness spreads and interacts with our immune system inside the body to make us sick.

Learn more about challenge studies with our blog.

What is pertussis?

Commonly called whooping cough, pertussis is a highly contagious infection of the bacteria Bordetella pertussis. The illness is named for the characteristic “whoop” noise caused by a sudden inhalation of air after a coughing fit that often occurs and is associated with the disease. There are 20–40 million cases of pertussis reported globally each year, 400,000 of those being fatal. Though illness in adults can be mild, symptoms can become severe in under-vaccinated and unvaccinated infants. Adults without full immunity can sometimes pass the infection on to more vulnerable people in their lives.

What do researchers want to find out?

Vaccines for pertussis have been available for decades, but vaccination and immunity from natural infections don’t protect a person for life.

There is limited understanding of pertussis’ ability to establish an infection, which pertussis antigens (disease-causing components) are the most effective targets for vaccines, or what type and amount of antibodies are needed to protect adults and children.

This study aims to help researchers further understand how pertussis infects the body, and answer other gaps in knowledge such as how the disease develops and the immune response to the infection.

Learn more about fading immunity to pertussis and how a challenge trial could help in our blog.

The main goal of the first study is to determine the amount of B. pertussis (dose) that results in only mild symptoms (similar to a common cold).

Am I able to Participate?

You can participate in the study if…

You are 18-40 years of age.
You are available for the entire residential stay in the Challenge Unit and during the outpatient period.
You are in good health.
Your physical examination and blood test at the screening visit are within normal limits.
You feel you will be able to stay in the Challenge Unit for the full 16-21 days and nights.

Sign Up

What will I have to do?

Introduction and Consent

If you’ve decided you’re interested in the challenge, you will first meet with a member of the study team who will fully explain the study process, its goals, and the risks and benefits to you. You are free to withdraw your consent at any time.
Medical Screening

Medical screenings assess your health and personal history to make sure you are healthy enough to participate. Typical procedures include blood collection, EKG, and urinalysis.
Study Invitation

If your lab results indicate you are healthy and eligible to participate, a team member will reach out directly to provide information regarding scheduling, items you can bring with you, and what the experience inside the Challenge Unit will be like.
The Challenge

When the study begins, you will be inoculated (given via liquid drops in the nose) with a small amount of virus or bacteria. In some studies, you may also be given a vaccine before the nasal drops.
Your Stay

Volunteers spend approximately 16-21 days in CCfV’s Challenge Unit, a highly specialized 10-bed hospital unit designed to fully contain respiratory infections. After the initial challenge, your time in the Unit will be your own, with the exception of daily blood tests and checkups which you will know about in advance. Healthcare support is available 24-7 to assist with and monitor participant safety and wellness. You can use this time to work remotely, catch up on a hobby, or simply relax!
Heading Home

All participants will receive appropriate antibiotic treatment to prevent severe illness. Five days after appropriate treatment, participants are no longer contagious. When you are feeling better and no longer contagious, you are able to go back to your normal life. If you are discharged before day 21 there will be a follow up phone call every day until day 21 to ask about symptoms.
After day 21, you will be asked to come back to the Challenge Unit for 9 short visits over the next 12 months.