AuthorisedPhase II and Phase III (Integrated)Interventional

Durability of Immunity induced by the Ebolavirus Vaccine VSV-EBOV and Assessment of a Booster Dose for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebolavirus Exposure: a German Multicenter Study (PREPARE-Germany)

This research, called PREPARE-Germany, is investigating the Ebola vaccine, Ervebo. It aims to understand how long the protection (immunity) from this vaccine lasts over two years in adults who are at risk of catching Ebola because of their job. The study will also explore if giving a booster dose of the vaccine helps to increase or prolong this protection. By measuring specific markers in the blood, researchers hope to learn more about the vaccine's long-term effectiveness. This information is important for people who work in areas where Ebola might be present, helping to ensure they have the best possible protection against the virus.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

University Medical Center Hamburg-Eppendorf

Enrolment target

Start

18 Oct 2024

Ebola virus infection

What is this study about?

This study is called PREPARE-Germany, and it's all about understanding how well and for how long the Ebola vaccine, called Ervebo, protects people. Imagine your body's immune system as a shield against germs. When you get a vaccine, your body learns to build defenses. This study wants to see how strong that shield remains over time, specifically for up to two years after someone gets their first vaccine.

The researchers are focusing on adults in Germany who might face Ebola as part of their work. This could include healthcare workers or others who travel to areas where Ebola outbreaks have occurred. The main goal is to find out if the vaccine's protection lessens over time and if a booster shot (a second dose given later) can help to keep that protection strong and long-lasting. This is important for ensuring people at higher risk have reliable protection.

To figure this out, the study will check for special proteins in the blood called antibodies. These antibodies are like little soldiers that fight off the Ebola virus. By measuring how many of these soldiers are present at different times, researchers can tell how well the vaccine is working and for how long. The study will also keep an eye on any side effects to make sure the vaccine is safe.

Key takeaways

This study explores long-term Ebola vaccine protection.
It's for adults at occupational risk of Ebola exposure.
Researchers will check if a booster shot improves immunity.
The study lasts for two years and involves blood tests.
Potential benefits include enhanced protection from Ebola.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. This study is open to both men and women.

The study is specifically looking for people who might be at risk of coming into contact with the Ebola virus because of their job. This could include healthcare workers, laboratory staff, or others whose work takes them to places where Ebola might be present.

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 work in a role that puts you at potential risk of Ebola exposure?
Are you able to commit to a two-year study with regular visits and blood tests?
Are you comfortable receiving the Ebola vaccine and potentially a booster?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely receive the Ebola vaccine, Ervebo. The study will involve regular check-ups and blood tests over a period of 24 months, which is two years. These blood tests will help the researchers measure your body's response to the vaccine. There might also be a booster vaccination given at some point during the study. Throughout this time, your health will be carefully monitored for any side effects, especially in the first month after any vaccination. The total time you'd be involved in the study is two years.

Potential risks and benefits

Taking part in this study could offer the potential benefit of closer monitoring of your immunity against Ebola, and possibly receiving a booster vaccine if needed, which could enhance your protection. However, like all vaccines, Ervebo can have side effects, such as soreness at the injection site or flu-like symptoms, and these will be carefully monitored. There are also risks associated with blood tests, such as bruising. You have the right to withdraw from the study at any time without giving a reason, and this will not affect 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
Germany

Common questions

What is the main purpose of this study?

The main purpose is to see how long protection from the Ebola vaccine lasts and if a booster shot helps.

Who can join this study?

Adults aged 18 and over who might be at risk of Ebola due to their job can join.

What is Ervebo?

Ervebo is the name of the Ebola vaccine being studied.

How long does the study last?

Participants will be followed for 24 months, which is two years.

Will I get a booster shot?

The study aims to assess a booster dose, so some participants may receive one.

How to find out more

Official trial record

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