CompletedPhase IInterventional

A clinical trial to determine the safety and immune responses to a new vaccine against Hantavirus disease

Hantavirus is a serious illness, often caught from rats, that can cause organ failure and can even be deadly. There's currently no specific treatment or vaccine. This study is testing a new vaccine called MVA-Hanta. It uses a safe virus, similar to the smallpox vaccine, which has been changed to help your body recognise and fight Hantavirus. We want to see if this new vaccine is safe and if it makes your immune system respond well to the virus. We're looking for healthy people aged 18 to 50 years old to take part.

At a glance

Status

Completed

Phase

Phase I

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

30 Sep 2025

Estimated completion

16 Apr 2026

Hantavirus disease

What is this study about?

Hantavirus disease is a serious illness caused by different viruses. It's often spread to people by rats and can lead to symptoms like fever, tummy problems, bleeding issues, and organ failure. Sadly, it can be fatal in up to 15 out of every 100 cases. Right now, doctors can only treat the symptoms, as there are no specific medicines to cure the disease and no vaccine to prevent it.

This study is looking into a new vaccine called MVA-Hanta. Vaccines work by teaching your body's defence system, called the immune system, how to fight off viruses before you get sick. This new vaccine uses a similar, safe virus to the one used in smallpox and mpox vaccines. This safe virus has been specially changed to show your body parts of the Hantavirus, so your immune system can learn to recognise and fight it if you ever come into contact with the actual virus. This MVA virus has been given to many thousands of people before and is known to be very safe.

The main aim of this study is to see if MVA-Hanta is safe for people and if it helps their immune system create a strong response against Hantavirus. This is a very early-stage study, meaning it's the first time this specific vaccine is being tested in humans. Finding a safe and effective vaccine could be a big step forward in protecting people from this dangerous disease.

Key takeaways

Hantavirus disease is a serious, potentially fatal illness with no current vaccine.
This study tests a new vaccine, MVA-Hanta, for safety and immune response.
It uses a safe, modified virus similar to smallpox vaccine.
Healthy volunteers aged 18-50 are needed.
Participation involves two vaccine doses, regular monitoring, and blood tests over 6 months.
Side effects are expected to be mild, but serious reactions are rare and managed by the team.

Who may be eligible?

You might be able to take part in this study if you are a healthy adult between 18 and 50 years old. You need to be willing to follow all the study rules and allow the study team to speak with your family doctor about your health history. If you are a woman who could become pregnant, you must agree to use effective contraception throughout the study and have a negative pregnancy test before getting the vaccine.

However, you cannot take part if you have received another experimental drug or vaccine in the last 30 days, or if you plan to get one during the study. You also cannot join if you have already had a vaccine that uses the MVA virus (like some smallpox or mpox vaccines), or any other licenced or experimental vaccine in the last 30 days. You will also need to agree not to donate blood during the study.

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?
Are you willing to let the study team talk to your GP about your health?
Have you avoided other experimental treatments or vaccines in the last month?
If you are a woman, are you using effective birth control?
Are you willing to not donate blood during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive two doses of the MVA-Hanta vaccine, given 28 days apart. Depending on which group you are in, you will either receive one injection of 0.5 ml for each dose, or two injections of 0.5 ml for each dose. After each vaccination, you will stay for 1 hour to be monitored by a medical team.

Throughout the study, you'll record any symptoms you have in a diary, and there will be regular checks, including blood tests. You will be in the study for up to 6 months after your first vaccination. This will include up to 12 planned visits to the research unit and two follow-up phone calls. You will be provided with a thermometer and tape measure for self-assessment, and a card with a 24-hour contact number for the study doctor.

Potential risks and benefits

The main benefit of taking part is contributing to important research that could lead to a vaccine for Hantavirus disease, potentially helping many people in the future. As with any vaccine, you might experience some side effects. These are usually mild, like pain or redness where you had the injection, or flu-like symptoms. There's also a very rare chance of a serious allergic reaction called anaphylaxis, but the study team is fully trained and equipped to deal with this immediately. Your safety is our top priority, and you will be closely monitored. You are free to leave the study at any time, for any reason, and this will not affect your usual medical care.

Locations (1)

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

Not provided at time of registration
City only
-, England

Common questions

What is Hantavirus disease?

It's a serious illness caused by viruses, often carried by rats, which can lead to fever, bleeding problems, organ failure, and can be deadly.

What is MVA-Hanta?

It's a new vaccine being tested. It uses a safe virus, similar to the smallpox vaccine, adapted to help your body fight Hantavirus.

How many injections will I receive?

You will receive two sets of vaccinations, 28 days apart. Each set will be either one or two injections, depending on your group.

How long will I be involved in the study?

You'll be in the study for up to 6 months after your first vaccination, with up to 12 visits and two phone calls.

What are the common side effects?

Common side effects might include pain or redness at the injection site, or general flu-like symptoms. These are usually mild.

How to find out more

Alasdair Munro

a.munro@soton.ac.uk - Official trial record

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