RecruitingNot ApplicableInterventional

Safety, colonisation and immunogenicity following nasal inoculation with genetically modified Neisseria lactamica expressing Factor H binding protein and Neisseria adhesin A - a pilot controlled human infection study

This research is looking for improved ways to protect people from meningitis and sepsis (serious blood poisoning) caused by a specific germ called Neisseria meningitidis. These conditions are very serious, especially for young children and teenagers in the UK and worldwide. The study involves giving healthy adult volunteers a small dose of a harmless, genetically modified germ (Neisseria lactamica) through their nose. We want to see how the body reacts to this modified germ and if it could offer a new way to prevent meningitis in the future. Participants will have several visits over five weeks, follow simple infection control rules, and receive antibiotics at the end.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Southampton

Enrolment target

Start

18 May 2026

Estimated completion

01 Oct 2026

Neisseria meningitidis, meningococcal meningitis, Neisseria lactamica

What is this study about?

This study is a vital part of a larger research effort dedicated to finding better ways to shield people from meningitis and a severe form of blood poisoning called sepsis. Both are caused by a germ named Neisseria meningitidis. These conditions can be extremely dangerous, leading to death or long-term disability quite rapidly. They mainly affect young children and adolescents, and preventing them is a key global health priority.

The research specifically focuses on a new approach to prevention. Instead of a traditional vaccine, we're exploring whether a modified, harmless germ (Neisseria lactamica) can help. This modified germ is given directly into the nose. We want to understand if it can safely live in the nose and provoke an immune response that might protect against the dangerous Neisseria meningitidis germ.

By carefully observing how volunteers' bodies react to this modified germ, we hope to gather crucial information. This information could pave the way for developing innovative prevention strategies for meningitis and sepsis, helping to protect vulnerable groups in the future and contribute to the World Health Organisation's goal of defeating meningitis by 2030.

Key takeaways

This study aims to find new ways to prevent serious illnesses like meningitis and sepsis.
It involves giving healthy adult volunteers a harmless, modified germ through the nose.
The study takes about 5 weeks and involves several visits.
Participants will receive antibiotics at the end of the study.
While there's no direct benefit to you, your participation could help protect others in the future.

Who may be eligible?

This study is looking for two types of healthy adult volunteers: "challenge participants" and "contact participants." Challenge participants need to be between 18 and 45 years old, while contact participants (who share a bedroom with a challenge participant) can be a bit older, up to 55 years old.

To join, you must speak good English and be able to understand and follow all study instructions. We'll ask you to answer some questions and give your written consent to take part, including agreeing to infection control rules and to take antibiotics at the end. We'll also need your permission to discuss your medical history with your GP.

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 a healthy adult (18-45 years for challenge, 18-55 years for contact participants)?
Do you speak and understand English well?
Are you able and willing to follow all study instructions?
If female, are you able to use continuous effective contraception during the study?
Are you happy for your GP to discuss your medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit. After that, there will be seven study visits spread out over five weeks. This is a "controlled human infection study," meaning you'll be given a small, harmless dose of live bacteria through your nose. Both you and any contact participants will need to follow simple infection control rules throughout the study. At the very end, everyone involved will receive a course of antibiotics to make sure the study germ is cleared from your system. The total duration of your active involvement will be about five weeks.

Potential risks and benefits

It's important to know that you are unlikely to directly benefit from taking part in this study. However, the information we learn will be incredibly valuable in helping to develop future ways to prevent meningitis and its serious consequences for others. You might also gain some general insights into your own health during the process. We anticipate some minor risks, such as light bruising or tenderness where blood samples are taken. The dose of bacteria in your nose might cause brief irritation that quickly fades. The antibiotic given at the end (ciprofloxacin) can sometimes cause side effects like stomach aches, diarrhoea, feeling sick, tiredness, or headaches. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

University Hospital Southampton NHS Foundation Trust
Unverified
Southampton, England

Common questions

What is Neisseria meningitidis?

It's a germ that can cause very serious illnesses like meningitis (inflammation around the brain and spinal cord) and sepsis (blood poisoning).

What is the purpose of giving me a modified germ?

We want to see if this harmless, modified germ can safely live in your nose and help your body develop a protective response against the dangerous meningitis-causing germ.

Will I get meningitis from this study?

No, you will be given a genetically modified version of a *different*, harmless germ (Neisseria lactamica), not the one that causes meningitis. We expect it to be harmless.

Where does the study take place?

The study is run at the NIHR Clinical Research Facility at Southampton General Hospital in the UK.

Who is paying for this research?

The study is funded by the Medical Research Council in the UK.

How to find out more

Andrew Procter

andrew.procter@uhs.nhs.uk +44 (0)23 8120 4479 Official trial record

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