RecruitingPHASE1INTERVENTIONAL

Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis

This research aims to understand whooping cough (also known as pertussis) better. Researchers are conducting a special kind of study called a Controlled Human Infection Model (CHIM). This means healthy volunteers will be intentionally exposed to a specific type of whooping cough bacteria that is missing a part called pertactin. This particular bacteria is similar to those currently circulating. The main goal is to create a safe and controlled way to study how this type of whooping cough affects people, taking into account their past experiences with vaccination or previous infections, common in places like North America. By understanding this, scientists hope to develop better ways to prevent and treat whooping cough in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Dalhousie University

Enrolment target

Start

24 Nov 2025

Estimated completion

30 Apr 2027

Pertussis (Whooping Cough)

What is this study about?

Imagine scientists trying to understand a puzzle, and whooping cough is that puzzle. This study is like setting up a very controlled experiment to get a clearer look at one specific piece of that puzzle. Researchers want to create a special "human infection model" – this means they will carefully give a small number of volunteers a specific type of whooping cough bacteria.

The bacteria they're using is a version of whooping cough that's slightly different from others because it's missing something called 'pertactin'. This is important because the types of whooping cough going around today often lack this pertactin. By studying how this particular bacteria affects people in a controlled setting, scientists hope to learn more about how the disease behaves, especially in people who have either had the whooping cough vaccine or have been sick with it before. This information is particularly valuable for understanding how the disease spreads in places like North America.

Ultimately, by learning more about this specific type of whooping cough in a safe environment, researchers hope to gather vital information that could help them develop better vaccines or treatments in the future. It's all about understanding the enemy better to protect us from it more effectively.

Key takeaways

The study involves intentionally giving volunteers a specific type of whooping cough bacteria.
It aims to understand how this particular bacteria (missing 'pertactin') affects people.
Participants must be aged 18-50 and in good health, able to follow study instructions.
If you can get pregnant, strict birth control is required before, during, and after the study.
The goal is to gather information to help develop better ways to prevent and treat whooping cough.
You have the right to withdraw from the study at any time without penalty.

Who may be eligible?

To join this study, you need to be generally healthy and between 18 and 50 years old. Before you can take part, a doctor will make sure you’re in good health with a check-up.

It's very important that you can reliably attend all appointments and fill out any diary cards they give you. You'll also need to read and sign a consent form, which explains everything about the study.

If you are able to get pregnant, you must be using effective birth control for at least 28 days before the study starts and continue using it for 60 days after you've been given the bacteria. You will also need to have a negative pregnancy test right before starting. You are considered not able to get pregnant if you’ve had certain surgeries (like a hysterectomy) or have a medical condition that prevents it. Effective birth control means methods that are very good at preventing pregnancy, like certain types of hormonal birth control.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 50 years old?
Are you generally in good health?
Are you able to attend all possible study appointments and fill out forms?
If you are able to get pregnant, are you willing to use effective birth control for the whole study period and have a negative pregnancy test before starting?

Answer every question to see your result.

What does participation involve?

The description provided does not outline specific details about visits, assessments, medication, or the total duration of the study. However, based on the eligibility criteria, you would likely need to attend a screening visit for a health check-up and physical exam. If you are eligible, you would then receive the Bordetella pertussis J820 bacteria. The study requires you to complete diary cards and attend follow-up visits, ensuring that researchers can monitor your health and how your body reacts to the bacteria. The total duration of your participation, including these follow-up visits, is not specified but would be detailed in the informed consent form if you were to participate.

Potential risks and benefits

Potential benefits of taking part could include contributing to a better understanding of whooping cough, which may lead to improved vaccines or treatments in the future. However, there are potential risks, as you would be intentionally exposed to whooping cough bacteria, meaning you could experience symptoms of the illness. All risks and potential side effects would be fully explained before you agree to participate. You would also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Canadian Center for Vaccinology
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is whooping cough?

Whooping cough, also known as pertussis, is a very contagious disease that causes severe coughing fits, often followed by a 'whooping' sound when breathing in. It can be serious, especially for babies and young children.

What does 'pertactin-deficient' mean?

Pertactin is a specific part of the whooping cough bacteria. 'Pertactin-deficient' means the bacteria used in this study is missing this particular part. This is important because many whooping cough strains circulating today also lack pertactin.

Why expose people to whooping cough on purpose?

This type of study, called a 'Controlled Human Infection Model,' helps scientists learn exactly how the disease affects people in a very safe and monitored environment. This information is hard to get otherwise and can help develop better vaccines and treatments.

Will I get sick if I join this study?

By definition, you will be exposed to the whooping cough bacteria. This will be done under strict medical supervision and with careful monitoring, but you should expect to develop symptoms similar to whooping cough. All potential symptoms and how they will be managed will be fully explained to you.

What happens if I decide I don't want to continue?

You are free to leave the study at any time, for any reason, without giving an explanation. Your decision will not affect your relationship with your doctor or your future medical care.

How to find out more

Nick Bartlett

nicholas.bartlett@iwk.nshealth.ca 902-470-8141 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.