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About the study

We are launching a pioneering clinical study to develop a new way to test vaccines and treatments against Staphylococcus aureus (often known as "Staph").

This study will establish a Controlled Human Infection (CHI) model. In this model, healthy volunteers are given a carefully controlled and safe dose of bacteria to induce a mild, localised skin infection in the presence of a surgical suture. By observing this process in a safe, in-patient environment, we can learn exactly how the immune system fights the bacteria - knowledge that is critical for developing future vaccines.

Why is this research needed?

Staphylococcus aureus is a common bacterium that usually lives harmlessly in the nose, on the skin, and in the gut. However, it can turn into a formidable enemy, causing infections that range from painful boils to life-threatening conditions. It is the leading cause of surgical site infections, a massive problem for hospitals and a complication for patients recovering from surgery. As the bacteria become increasingly resistant to antibiotics, evolving into 'superbugs' like MRSA, our existing medicines are failing, and we still lack an effective vaccine.

This study aims to tackle this. By using a specialised 'suture model' that mimics the exact conditions of a surgical wound, we can study how these infections start in unprecedented detail. This will provide the essential data needed to develop the next generation of vaccines and preventative treatments.

What does participation involve?

This is a "Human Challenge" study. This means we are not just observing natural infections; we are deliberately inducing an infection to study it in real-time.

• The "Suture" method: This mimics how infections happen in the real world, especially surgical site infections. We use a small surgical thread (suture) to facilitate the infection. A dose of Staphylococcus aureus is introduced once the suture is in place.
• Inpatient stay: Participants stay with us in a specialised clinical research ward. This allows us to monitor you 24/7 and ensure that you are safe.
• The goal: We are looking to identify the specific dose of bacteria required to cause a mild, manageable skin infection in about half of the volunteers.

Your safety is our priority

Safety is the central focus of this study. While the concept of a "challenge" study may sound bold, it is a well-established scientific method used safely for decades to develop vaccines for typhoid, flu, and malaria. ³Ô¹ÏºÚÁÏ and collaborators on this study have extensive experience in this field.

• World-class care: You will be looked after by an expert medical and research team in a dedicated research facility.
• Close monitoring: We monitor for early signs of infection, such as redness or fever. We prevent the infection from becoming severe.
• Guaranteed treatment: All participants receive effective antibiotics and have the suture removed after a set period of time (or sooner if necessary) to ensure the infection is completely cleared.
• Experienced team: The study is led by Dr Dinesh Aggarwal and supported by renowned experts in infectious disease, including Professor Christopher Chiu, Professor Shiranee Sriskandan, Dr Malick Gibani, and Dr Alex McCarthy, and other world-renowned collaborators.

Who funds this research?

This study is one of the six ‘Grand Challenge’ research programmes established and supported by the partnership between GSK and the Fleming Initiative, which harness some of the best scientific expertise and the latest technologies to find new ways to slow the progress of antimicrobial resistance (AMR). 

The Fleming Initiative – a groundbreaking collaboration established by ³Ô¹ÏºÚÁÏ and ³Ô¹ÏºÚÁÏ College Healthcare NHS Trust - brings together research scientists, policymakers, clinicians, behavioural experts, public and commercial partners to provide the networks, expertise and skills to provide equitable solutions to AMR at a global scale.

Register your interest

We are looking for healthy adult volunteers to help us advance this vital medical research.

If you are interested in learning more, please register your interest below. We will provide further information in due course.