RecruitingNAINTERVENTIONAL

Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

This study aims to understand more about whooping cough (pertussis) by carefully studying how the germ, called Bordetella pertussis, behaves in healthy adults. Volunteers will get a small, controlled amount of the germ sprayed into their nose. Researchers will then observe how long the germ stays, how the body reacts, and when symptoms start. Antibiotics will be given carefully: either six weeks after getting the germ, or sooner if someone starts feeling ill. The study also wants to see if the germ can spread to people sharing a bedroom with volunteers. This research helps us learn more about whooping cough, how it spreads, and how best to treat it.

At a glance

Status

Recruiting

Phase

Sponsor

University of Southampton

Enrolment target

Start

06 Dec 2022

Estimated completion

01 Dec 2026

Healthy Volunteer Study

What is this study about?

This study is about learning more about whooping cough, a common and sometimes serious illness, especially for babies. We usually get vaccinated against whooping cough, but doctors still don't fully understand how the germ that causes it, called _Bordetella pertussis_, behaves in the body, how quickly it's naturally cleared, or how best to stop it spreading.

In this research, healthy adult volunteers will have a tiny, controlled amount of the whooping cough germ put into their nose. This isn't aimed at making people very sick, but at safely seeing how the body reacts over a few weeks. The main goal is to check how safe this process is and to see how long the germ stays in the nose before people are given antibiotics to clear it. Antibiotics will be given either after six weeks or sooner if someone develops symptoms.

The study also has other important aims. It will look at how the germ changes over time, how the body's immune system fights it, and critically, if the germ can spread to close contacts, like someone sharing a bedroom. By understanding these things better, scientists hope to develop better ways to prevent and treat whooping cough for everyone.

Key takeaways

Study aims to understand whooping cough germ (`B. pertussis`) better.
Healthy volunteers receive a small, controlled dose of the germ in their nose.
Antibiotics will be given after 6 weeks or sooner if symptoms appear.
Strict infection control is required to prevent spread.
Study also observes if the germ can spread to close contacts (bedroom sharers).
Results could lead to improved prevention and treatment of whooping cough.

Who may be eligible?

To join this study, you need to be a healthy adult aged between 18 and 55. You must be able to understand and speak English well and be comfortable using a mobile phone, email, and text messaging for communication. It's important that you're willing to follow all the study rules and attend appointments.

There are some important reasons why you might not be able to join. You can't take part if you live with or will be in close contact with very young babies (under one year old) who haven't been fully vaccinated, pregnant women in their later stages who haven't had a recent whooping cough jab, people with weakened immune systems, or very frail individuals. This is to protect these vulnerable people from any possible risk. Also, you can't join if you live in a shared dormitory setting, like a boarding school.

Quick self-check

Are you between 18 and 55 years old?
Do you speak and understand English well?
Do you NOT live with an unvaccinated baby, a heavily pregnant woman, or someone with a very weak immune system?
Are you willing to follow infection control rules and attend weekly appointments?
Do you NOT live in shared dormitory accommodation (like a boarding school or military barracks)?
Are you able to use a mobile phone, email, and text?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a screening appointment to check you're healthy enough for the study. If you're suitable, a small, controlled amount of the whooping cough germ will be gently sprayed into your nose. After this, you'll have weekly check-ups and samples taken from your nose to see if the germ is still there.

You'll be given antibiotics to clear the germ either six weeks after it was put into your nose, or sooner if you start to develop any symptoms of whooping cough. It's really important that you follow special infection control rules during social contact for the study duration to prevent any spread. If you live with someone who wants to take part as a 'contact' volunteer, they will also be monitored to see if the germ spreads. The total study duration for each volunteer is about six weeks, plus a few days for follow-up.

Potential risks and benefits

Taking part in this study could help scientists better understand whooping cough, which may lead to improved ways of preventing and treating this illness for everyone in the future. Potential risks include getting mild whooping cough symptoms, though these will be monitored closely and treated with antibiotics. There's also a small risk of spreading the germ to close contacts if infection control measures aren't strictly followed, which is why vulnerable household members are excluded. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

NIHR Clinical Research Facility
Southampton, United Kingdom· Recruiting

Common questions

What is whooping cough?

Whooping cough (also known as pertussis) is a highly contagious lung infection that causes severe coughing fits, which can sometimes end with a 'whooping' sound as you breathe in.

Why would I get the whooping cough germ on purpose?

Scientists carefully give a small amount of the germ to healthy volunteers to learn exactly how it affects the body over time. This helps them understand the illness better and develop new treatments or vaccines.

Will I get really sick?

You might experience some mild whooping cough symptoms. However, the study is designed to be safe, with close monitoring and antibiotics given to stop the infection from becoming severe or lasting too long.

Will my family be at risk?

The study has strict rules about who can take part, especially to protect vulnerable people like babies or pregnant women. If you live with any such individuals, you won't be able to join. You will also be asked to follow precautions to prevent spread to others.

What happens if I change my mind?

You are absolutely free to leave the study at any point, for any reason. Your decision will not affect your medical care.

How to find out more

Robert Read

r.c.read@soton.ac.uk 023 8120 4989 Official trial record

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