Active not recruitingOBSERVATIONAL

Covid-19 Vaccine Immune Response in Multiple Sclerosis

COVID-19 vaccines have been given to millions, including those with Multiple Sclerosis (MS). However, we don't fully know if people with MS create enough protective antibodies, or how long these antibodies last after vaccination. This study aims to find out. Researchers will take blood samples from people with MS who have received their COVID-19 jabs, and compare their immune response to a group of healthy volunteers. The main goal is to see if the vaccines trigger a similar level of protection in both groups, helping us understand vaccine effectiveness for people living with MS.

At a glance

Status

Active not recruiting

Sponsor

University Hospitals of North Midlands NHS Trust

Enrolment target

240

Start

16 Feb 2022

Estimated completion

30 Dec 2025

Multiple Sclerosis

What is this study about?

Coronavirus (Covid-19) has impacted many lives worldwide, and vaccines were developed to help protect people from getting very sick. These vaccines have been offered to lots of people, including those with Multiple Sclerosis (MS). However, it's not fully clear if people with MS get the same amount of protection from these vaccines, or how long that protection might last.

This study wants to understand this better. Researchers will look closely at the immune system of people with MS after they've had their full course of Covid-19 vaccinations. They will check things like how many protective 'antibodies' – which are special cells that fight off infections – their bodies produce. This information is really important because it helps doctors and patients understand how well the vaccines work for people with MS.

To make sure the results are accurate, the study will compare people with MS to a group of healthy volunteers who don't have MS or other conditions that affect the immune system. Everyone in the study will have had their Covid-19 vaccines. By comparing these two groups, scientists hope to learn if people with MS develop a similar level of protection from the vaccine.

Key takeaways

The study investigates how well COVID-19 vaccines work for people with MS.
It aims to measure the protective antibodies produced after vaccination.
Participation involves giving a few blood samples.
The study compares people with MS to healthy volunteers.
Findings could help provide better advice for people with MS regarding vaccines.

Who may be eligible?

To join the study if you have MS, you need to be 18 or older and have a confirmed diagnosis of MS. You also need to be on one of several specific MS treatments (like Ocrelizumab, Natalizumab, or Alemtuzumab, among others) or not on any treatment currently. Crucially, you must have completed your full course of Covid-19 vaccinations, including any booster jabs, as per UK guidelines. You also need to be willing to give your informed consent and follow the study's instructions.

For those without MS who want to be part of the healthy control group, you also need to be 18 or older and have had your full Covid-19 vaccination course. You shouldn't have MS or any other long-term health condition that affects your immune system, or have taken medicines that suppress your immune system in the last five years. Again, you'll need to agree to take part and follow the study rules.

Anyone who has chosen not to have the Covid-19 vaccine, has recently changed their MS medication around the time of their vaccine, or has other immune conditions that could affect the results won't be able to join. Also, if you were unable to have the Covid-19 vaccine for health reasons or government prioritisation, you wouldn't be eligible.

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 aged 18 or older?
Do you have a diagnosis of Multiple Sclerosis (MS)? (Or are you a healthy volunteer without MS?)
Have you had your full course of COVID-19 vaccinations (including boosters) as per UK guidelines?
Are you willing and able to attend appointments for blood tests?
Have you NOT changed your MS medication around the time of your first COVID-19 vaccine?
Do you NOT have any other major conditions that affect your immune system?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll need to do is provide some blood samples. These 'blood tests' will help the researchers measure your immune response to the Covid-19 vaccine, specifically looking at the protective antibodies your body has made. There will be at least two blood tests, and the study team will let you know the exact schedule.

Apart from the blood tests, you'll also have a conversation with the study team to make sure you understand everything about the study and to give your consent to participate. You won't need to take any new medication as part of this study; it's purely about checking your body's reaction to the Covid-19 vaccines you've already received. The study team will explain the total duration of your involvement, but it will mainly involve these few appointments for blood samples.

Potential risks and benefits

Participating in this study might help us understand how Covid-19 vaccines protect people with MS, which could benefit others with MS in the future. You won't receive direct medical benefits from taking part. The main risks are minor discomfort or bruising from the blood tests, which are generally very safe procedures. You have the right 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 Hospitals of North Midlands NHS Trust
Verified postcode
Stoke-on-Trent, United Kingdom

Common questions

What is an 'immune response'?

An immune response is how your body's defence system reacts to something like a vaccine or infection, trying to protect you.

What is Multiple Sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, impacting movement, balance, and other body functions.

Why is this study important for people with MS?

It helps us learn if Covid-19 vaccines offer the same protection to people with MS as they do to others, which is vital for their health.

Do I need to take any new medicine for this study?

No, you don't need to take any new medicines. The study only looks at your body's reaction to the Covid-19 vaccines you've already had.

What's a 'control group'?

A control group is a group of healthy volunteers who don't have MS. Comparing their results helps researchers understand the findings better.