CompletedPhase IInterventional

A study to evaluate the safety and effects on the immune system of a tetanus and diphtheria vaccine which does not need any cold chain distribution or storage

We're looking for healthy adults, aged 18-55, to take part in a study testing a new tetanus and diphtheria (Td) vaccine. This new jab, called SPVX02, is special because it doesn't need to be refrigerated, which could make it easier to deliver in different places. The study wants to check if SPVX02 is safe, if it causes side effects, and if it helps your body build protection against tetanus and diphtheria as effectively as two other existing Td jabs. Participants will receive one jab and have a few check-ups over about a month. Your health will be carefully watched throughout the study.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Stablepharma Ltd

Enrolment target

Start

17 Feb 2025

Estimated completion

26 Aug 2025

Prevention of tetanus and diphtheria infection in healthy volunteers

What is this study about?

This study is about a new type of jab for tetanus and diphtheria, two serious infections. Tetanus can cause muscle spasms and lockjaw, and diphtheria can lead to breathing problems and heart damage. Most people get jabs for these as children and then booster jabs throughout their lives to keep up their protection.

The exciting thing about this new jab, called SPVX02, is that it's designed not to need refrigeration. Most vaccines need to be kept cold, which can be a challenge in some parts of the world or during emergencies. If this new jab works well and is safe, it could make it much easier to protect more people against these diseases. This study is the first step (called 'Phase I') in testing this new jab.

We want to see if SPVX02 is safe, how well people tolerate it (meaning, how many side effects they get), and if it helps create the right kind of protection in their bodies. To do this, we'll be comparing it to two other jabs that are already available or well-known, called Tetadif® and diTeBooster®. We want to make sure the new jab works just as well at boosting your protection.

Key takeaways

The study is testing a new tetanus and diphtheria jab (SPVX02) that doesn't need refrigeration.
It aims to see if SPVX02 is safe and works as well as current jabs.
Healthy adults (18-55) are needed, who've had previous Td jabs but not a booster in the last 10 years.
Participants get one jab, track symptoms for 7 days, and have clinic visits on day 7 and day 28.
Potential side effects are similar to other jabs (pain, swelling, fever), and you'll be monitored closely.
Taking part helps research that could make jabs more accessible globally.

Who may be eligible?

We are looking for healthy adults, aged between 18 and 55. You need to have had your tetanus and diphtheria jabs before, but you mustn't have had a booster jab for these in the last 10 years. This helps us see how well the new jab boosts your existing protection.

It's important that you are generally well and don't have any health conditions that affect your immune system (your body's defence system). You also need to be able to understand what the study involves and agree to take part. We will ask you about your medical history to make sure the study is suitable for you.

If you are a woman who could become pregnant, you'll need to be using reliable contraception during the study. This is a common safety measure in many new jab 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 55 years old?
Are you generally healthy, with no conditions affecting your immune system?
Have you had tetanus and diphtheria jabs before (as a child or adult)?
Have you NOT had a tetanus and diphtheria booster jab in the last 10 years?
If you could become pregnant, are you using a reliable method of contraception?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given a single jab of either SPVX02, Tetadif, or diTeBooster – which one you get will be decided by chance, like flipping a coin. After your jab, you'll stay at the clinic for at least 30 minutes so we can check on you. You'll also be given a small electronic diary, a tape measure, and a thermometer to record any changes or side effects at home for the first 7 days.

You'll get a follow-up phone call the day after your jab. You'll then need to return to the clinic for check-ups on day 7 and day 28 after your jab. These visits will involve various assessments to see how you're doing and how your body is responding to the jab. The study lasts for about a month from your jab date until your final clinic visit.

Potential risks and benefits

Like all medicines and jabs, there are possible side effects. You might experience common ones such as pain, redness, or swelling where you had the injection. You could also feel generally unwell, with a fever, tiredness, or a headache. Rarely, more serious reactions like severe allergies can happen. We will watch you closely for at least 30 minutes after your jab to manage any immediate reactions. Your safety is our top priority. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care. The main benefit is helping us learn more about this new jab and potentially improving future global health.

Locations (3)

NIHR Southampton Clinical Research Facility
City only
Southampton, England
Medicines Evaluation Unit Limited
City only
Manchester, England
Queen Alexandra Hospital
Approximate
Portsmouth, England

Common questions

What are tetanus and diphtheria?

Tetanus and diphtheria are serious bacterial infections. Tetanus causes muscle spasms and can be life-threatening, while diphtheria can lead to breathing difficulties, heart problems, and nerve damage.

Why is a jab that doesn't need to be kept cold important?

Most jabs need refrigeration, which can be hard in places without reliable electricity or during emergencies. A jab that stays stable at room temperature would be easier to store and transport, helping more people get protected.

Will I know which jab I receive?

This is a 'single-blind' study, meaning you won't know which of the three jabs you've been given. This helps make sure the results are fair and unbiased.

What happens if I have side effects?

You will be monitored after your jab, and you'll have specific instructions on what to do if you experience any side effects. Our medical team will be available to support you.

Will I get paid for taking part?

The information provided doesn't mention payment for participation, but usually travel expenses might be reimbursed. You should ask the study team for details.

How to find out more

Karen O'Hanlon

kohanlon@stablepharma.com +44 (0)7812606184 Official trial record

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