RecruitingPHASE4INTERVENTIONAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

Pneumococcal bacteria can live harmlessly in people's noses but can spread and cause serious illness, especially for vulnerable individuals. Current vaccines, like PCV13, protect against some types of these bacteria by stopping them from living in the nose. A new vaccine, PCV15, might protect against even more types. This study, lasting two months, aims to see if PCV15 can prevent people from carrying these bacteria. Volunteers will either receive the PCV15 vaccine or a dummy treatment. After a month, a small, safe amount of the bacteria will be put into their nose to see if the vaccine works. Everyone will receive antibiotics afterwards and be closely monitored for safety.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Oxford

Enrolment target

106

Start

24 Feb 2025

Estimated completion

01 Dec 2026

Pneumococcal Disease Pneumococcal Carriage

What is this study about?

This research is looking into a new vaccine called PCV15. It's designed to protect against a type of bacteria called pneumococcus. These bacteria are quite common – they often live in people's noses without causing any bother. But they can spread to others and, for some, like the elderly, very young, or those with other health problems, they can cause serious lung infections (like pneumonia).

Existing vaccines, like PCV13, are very good at stopping these bacteria from settling in the nose. This is important because if the bacteria don't 'set up home' in someone's nose, they are much less likely to cause illness themselves or to spread to others. The new PCV15 vaccine is similar but aims to protect against two extra types of these bacteria, which could provide even more protection for more people.

The study wants to find out if PCV15 can prevent people from carrying these bacteria in their nose. This is a crucial step towards developing better vaccines. Understanding how PCV15 works will help improve both this vaccine and future ones, potentially saving many lives around the world.

Key takeaways

This study tests a new vaccine, PCV15, for pneumococcal bacteria.
It aims to see if the vaccine stops you carrying the bacteria in your nose.
You'll either get the real vaccine or a dummy, then have a small amount of bacteria placed in your nose.
The study lasts 2 months, with regular check-ups and antibiotics at the end.
Your safety is a priority and you'll be closely monitored throughout.
Your participation helps improve future vaccines to protect many lives.

Who may be eligible?

To be part of this study, you need to be a healthy adult aged between 18 and 50 years old. You should feel well and not have any serious health conditions that might need hospital treatment during the study. It's important that you can understand and speak English well and can attend all the appointments and follow the study instructions.

There are also some things that would mean you can't join. For example, if you've been in a similar research study involving pneumococcal bacteria in the last two years, or if you're already taking part in another study that might interfere with this one. If you've recently had certain vaccines or have allergies to vaccine ingredients, you also wouldn't be able to participate. They'll also check if you have any conditions that affect your immune system, as this study wouldn't be suitable then.

Women who could become pregnant must agree to use effective contraception throughout the study and have pregnancy tests. You'll also need to share your medical history and allow the study team to inform your GP that you're taking part, and register on a system that tracks people who volunteer for many studies.

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 healthy and don't expect to need hospital care soon?
Can you speak and understand English well?
Are you able to attend all study appointments over two months?
If you could become pregnant, are you willing to use effective contraception?
Are you okay with your GP being informed and sharing your medical history?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for about two months. You would first have an appointment where you get either the PCV15 vaccine or a 'dummy' injection (called a placebo). A month later, you would have a very small, safe amount of pneumococcal bacteria put into your nose. This is called a 'challenge'. After this, you'll be monitored regularly for 28 days to see if the bacteria settle in your nose and how your body reacts.

Throughout the study, you'll have clinic visits for check-ups and to provide samples, and you'll be asked to keep a diary of how you're feeling using an online tool. At the very end of the study, everyone will be given a course of antibiotics to make sure any pneumococcal bacteria that might have settled in their nose are completely cleared. Your safety will be a top priority, and you'll be looked after by the medical team throughout.

A small number of volunteers might also be asked to have small tissue samples (biopsies) taken from inside their nose before and after vaccination. This is to help researchers understand more deeply how the vaccine affects the body's immune system. These participants would not be given the bacteria challenge. In total, the study involves several visits to the clinic.

Potential risks and benefits

Potential benefits of taking part include contributing to important medical research that could lead to better vaccines and protect many people from serious illness in the future. You will also receive careful medical monitoring throughout the study. Potential risks include discomfort from injections, having bacteria put into your nose, and the small chance of side effects from the vaccine or a mild reaction to the bacteria, though you will be closely monitored and given antibiotics to clear any bacteria. For those having biopsies, there's a risk of mild discomfort or bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Liverpool Vaccine Group
Verified postcode
Liverpool, United Kingdom· Recruiting
Oxford Vaccine Group
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is pneumococcal disease?

It's an illness caused by pneumococcus bacteria, which can lead to serious lung infections like pneumonia, especially in vulnerable people.

Is it safe to have bacteria put in my nose?

Yes, a very small, carefully controlled amount of bacteria will be used, and you'll be closely monitored. Everyone gets antibiotics afterwards to clear the bacteria.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real vaccine but doesn't contain any active ingredients. It helps researchers compare the effects of the actual vaccine.

How long will I be in the study?

The study lasts for about two months, including your vaccination, the 'challenge', and follow-up appointments.

Will I know if I got the real vaccine or the placebo?

No, neither you nor the study doctors will know who got which until the end of the study. This helps keep the results fair and unbiased.

How to find out more

Carla Solorzano-Gonzalez, PhD

carla.solorzanogonzalez@paediatrics.ox.ac.uk +44 1865 611400 Official trial record

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