Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination after topical application of IMIQUIMOD, in cirrhotic patients, who did not respond to the conventional vaccine regimen: a pilot study

This research is for people with liver scarring, also known as cirrhosis, who have previously had the standard Hepatitis B vaccine but it didn't protect them. The study aims to find out if giving the Hepatitis B vaccine as a small injection just under the skin, especially after applying a special cream called Imiquimod, can help their bodies produce enough protection (antibodies) against the virus. Researchers will check the level of these protective antibodies several months after the injections to see how well it works. They will also carefully monitor for any side effects to make sure the new vaccination method is safe. This is a pilot study, meaning it's an early look into a new way of vaccinating.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

CHRU De Nancy

Enrolment target

Start

26 Jun 2024

What is this study about?

This study is designed for individuals who have liver cirrhosis and have already received the standard Hepatitis B vaccine, but unfortunately, it didn't work for them. This means their body didn't produce enough protective antibodies to fight off the Hepatitis B virus, leaving them vulnerable to infection. The main goal of this research is to explore a different way of giving the Hepatitis B vaccine to see if we can improve protection in this group of patients.

The researchers are testing a method that involves injecting the vaccine just under the skin (this is called 'intra-dermal'). They are also investigating whether applying a special cream called Imiquimod to the skin before this injection can boost the vaccine's effectiveness even further. The Imiquimod cream is thought to help the immune system respond better to the vaccine.

Over several months, the study will focus on measuring the levels of protective antibodies in the participants' blood to see if this new vaccination approach helps their bodies produce enough protection. They will also be closely watching for any side effects to make sure the method is safe. This study is an important step in trying to find better ways to protect people with cirrhosis from Hepatitis B.

Key takeaways

This study is for people with cirrhosis who didn’t respond to the standard Hepatitis B vaccine.
It tests a new way of giving the vaccine, sometimes with a special cream called Imiquimod.
The main goal is to see if this new method helps produce protective antibodies.
Researchers will also carefully check for any side effects to ensure safety.
Participation involves several injections and blood tests over approximately seven months.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part.

To be eligible, you must have liver cirrhosis, which is a type of serious liver scarring. Crucially, you must have previously received the conventional Hepatitis B vaccine course, but your body did not respond to it. This means that after completing your vaccine course, a blood test showed that your level of protective antibodies against Hepatitis B was too low (specifically, less than 10 units per millilitre).

If you meet these criteria, you might be a suitable candidate for this research and could help us learn more about potential new vaccination methods.

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?
Do you have liver cirrhosis?
Have you had the full standard Hepatitis B vaccine series before?
Did a blood test show that the standard vaccine didn't protect you (antibody level less than 10 units/ml)?
Are you able to attend appointments over a seven-month period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a series of Hepatitis B vaccinations over several months. Some participants will also apply a special cream called Imiquimod to their skin before receiving the vaccine. You will have regular appointments over approximately seven months, which will include blood tests to measure your antibody levels and check your general health. Researchers will also closely monitor you for any potential side effects throughout the study after each vaccination. The total time you will be involved in the study from your first injection until the last check-up will be around seven months.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping your body develop protection against Hepatitis B, which the standard vaccine hasn't achieved. However, there's no guarantee the new method will work for you. There might be some risks, such as side effects from the vaccine or the Imiquimod cream, which could include redness, itching, or soreness at the injection or application sites. More serious side effects are possible but rare. 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.

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Unverified
France

Common questions

What is Hepatitis B and why is vaccination important?

Hepatitis B is a virus that can cause serious liver damage. Vaccination helps your body build protection against the virus.

What does 'cirrhosis' mean?

Cirrhosis is when your liver has severe scarring, making it harder for it to work properly.

Why didn't the usual vaccine work for me?

For some people, especially those with certain health conditions like cirrhosis, the immune system doesn't respond well to standard vaccines. This study is trying to find a better way for you.

What is Imiquimod cream?

Imiquimod is a cream sometimes used to help stimulate the body's immune system. In this study, it's being tested to see if it helps the vaccine work better.

Will I know if the new vaccine works for me?

Yes, blood tests will be taken regularly to measure your protective antibody levels, and you will be informed of the results.