Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Prospective Randomized trial of Everolimus replacing MMF/MP Acid by the RECOVAC consortium to increase VACcine response in kidney transplant patients

This research is investigating how kidney transplant patients respond to important vaccines, specifically for COVID-19 and Shingles (Herpes Zoster). When you have a kidney transplant, your immune system is often weaker due to the anti-rejection medicines you take, which means vaccines might not work as well. This study compares two different types of anti-rejection drug approaches. Some patients will continue with their current treatment (MMF/MPA, known by brand names like CellCept or Myfortic), while others will switch to a different medication called Everolimus (brand name Certican). The main goal is to see if switching to Everolimus helps patients produce more protective antibodies against COVID-19 after vaccination, and also to check their response to the shingles vaccine.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Universitair Medisch Centrum Groningen, Universitair Medisch Centrum Groningen

Enrolment target

110

Start

01 Jun 2023

kidney transplantation COVID-19 Herpes Zoster impaired immunity

What is this study about?

This study, called RECOVAC, is exploring a crucial topic for people who have had a kidney transplant. When you receive a new kidney, you need to take special medications to stop your body from rejecting it. However, these medicines can also weaken your immune system, making it harder for your body to fight off infections, even after you've had a vaccine. This means that vaccines, like those for COVID-19 and Shingles, might not protect you as well as they do for someone with a healthy immune system.

Researchers want to find out if changing one of these anti-rejection medications can help your immune system respond better to these important vaccines. They are comparing two groups of patients. One group will continue with their usual anti-rejection medication, commonly known as MMF or MPA (brand names include CellCept and Myfortic). The other group will switch to a different medication called Everolimus (brand name Certican). The main focus is to see which group develops a stronger immune response, measured by the amount of protective antibodies in their blood, after getting the updated COVID-19 vaccine.

Beyond just looking at COVID-19, the study will also investigate how well patients respond to the Shingles vaccine. They will also keep a close eye on other important health factors, such as how well the new kidney is working, whether there are any rejections, and if patients experience any side effects from the medications or vaccines. This research is important because it could help doctors make better decisions about which medications offer the best protection against infections for kidney transplant patients.

Key takeaways

Aims to improve vaccine protection for kidney transplant patients.
Compares two different anti-rejection medication approaches.
Focuses on immune response to COVID-19 and Shingles vaccines.
Monitors kidney function and potential side effects.
Participation involves blood tests and clinic visits.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have had a kidney transplant and are currently taking certain anti-rejection medications.

The research team will have a detailed list of other medical conditions or medications that might mean you can't join. This is usually to make sure the study is as safe as possible for everyone involved and that the results are clear. For example, if you have other serious health problems, the researchers might decide it's not appropriate for you to participate.

It's always best to discuss your full medical history with the study doctor or nurse. They can confirm if this study is a good fit for you based on all your individual circumstances.

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 18 years old or older?
Have you had a kidney transplant?
Are you currently taking anti-rejection medications?
Do you feel comfortable with receiving COVID-19 and Shingles vaccines?
Are you able to attend regular clinic visits for checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups: either you'll continue with your current anti-rejection medication (MMF/MPA), or you'll switch to a new anti-rejection medication called Everolimus (Certican). You won't get to choose which group you're in, as this is decided randomly to make the study fair.

You will receive specific vaccines for COVID-19 (the Omicron XBB.1.5 strain) and Shingles (Shingrix) as part of the study. The medical team will take blood samples at specific times to measure your immune response (how many antibodies you're making) to these vaccines. They will also check your kidney function and look for any side effects.

Throughout the study, you'll have regular visits to the clinic for check-ups and sample collections. The exact number of visits and the full duration of your participation will be explained in detail by the study team. Some of these visits will focus on your response 28 days after each vaccination. The study will also monitor any side effects for a week after each vaccine dose.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping us understand how to improve vaccine protection for kidney transplant patients, which might lead to better health outcomes in the future. There's a chance you might personally develop a stronger immune response to the vaccines, but this is not guaranteed for everyone. As with any medical study, there are potential risks, such as side effects from the study medications or vaccines, including allergic reactions or short-term discomfort at the injection site. There's also a risk that switching medications might affect your kidney or cause other side effects. You are 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.

—
Unverified
Netherlands

Common questions

What is the main goal of this study?

The main goal is to find out if changing anti-rejection medication helps kidney transplant patients respond better to COVID-19 and Shingles vaccines.

What medications are being looked at?

The study compares your current anti-rejection medicines (like CellCept or Myfortic) with a different one called Everolimus (Certican).

Will I get to choose which medicine I take?

No, you won't choose. Which medicine you take will be decided by chance, like flipping a coin, to make the study fair.

What kind of vaccines will I receive?

You will receive the updated COVID-19 vaccine (Omicron XBB.1.5) and the Shingles vaccine (Shingrix).

How long will I be in the study?

The exact length of your participation will be explained by the study team, but it involves monitoring your health and immune response for a period after your vaccinations.