Study on the Long-Term Immunity of the Ebola Vaccine VSV-EBOV and Booster Dose for Workers at Risk of Ebola Exposure

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What is this study about?

This clinical trial is focused on studying the effectiveness of a vaccine called Ervebo, which is used to protect against Ebola virus infection. The vaccine is a solution for injection and is designed to help the body build immunity against the Ebola virus. The study aims to understand how long the immunity lasts after receiving the vaccine and to assess the benefits of an additional booster dose for people who might be at risk of coming into contact with the Ebola virus due to their work.

The purpose of the study is to compare the immune response in individuals who receive the Ervebo vaccine with and without a booster dose. Participants will receive the initial vaccination and then, after six months, some will receive a booster dose while others will not. The study will monitor the participants’ immune responses over a period of 24 months to see how well the vaccine works in maintaining immunity against the Ebola virus.

Throughout the study, participants will have their blood tested to measure the levels of antibodies, which are proteins the body makes to fight infections like the Ebola virus. The study will also keep track of any side effects that occur after the vaccinations. This research is important for understanding how to best protect people who might be exposed to the Ebola virus in their work environments.

1 initial vaccination

Upon joining the study, you will receive an initial dose of the Ervebo solution for injection, which is a vaccine designed to protect against the Ebola virus. This vaccine is administered as an intramuscular injection, meaning it is injected into a muscle.

The purpose of this initial vaccination is to help your body develop an immune response to the Ebola virus.

2 follow-up visits

After the initial vaccination, you will have follow-up visits to monitor your health and the immune response to the vaccine. These visits will occur at regular intervals over a period of 24 months.

During these visits, blood samples may be taken to measure the levels of antibodies, which are proteins your body makes to fight the virus.

3 booster dose or no booster

At the 6-month mark, you will be randomly assigned to either receive a booster dose of the vaccine or not receive a booster. This is to assess the effectiveness of an additional dose in maintaining immunity.

If you receive the booster, it will be administered in the same way as the initial dose, as an intramuscular injection.

4 monitoring and final assessments

Throughout the study, you will be monitored for any side effects or adverse events. This includes any significant health changes that occur after vaccination.

The study will conclude with final assessments at the 24-month mark, where your immune response will be evaluated to determine the long-term effectiveness of the vaccine.

Who Can Join the Study?

Must be at least 18 years old.
Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.
Must be at risk of coming into contact with the Ebola virus through work in a lab, clinic, or fieldwork, as determined by the study team.
If you are a female who can have children, you must agree to use effective birth control methods from at least 30 days before getting the vaccine until 2 months after the vaccination or booster.
Must agree to avoid contact with blood and body fluids from high-risk individuals for 6 weeks after getting the vaccine or booster.
Must agree not to donate blood from 30 days before the first vaccination until the end of the study.
Must be willing to be randomly assigned to either receive a booster shot or not at the 6-month visit.

Who Cannot Join the Study?

Patients who are not infected with the Ebola virus.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the rVSVΔG-ZEBOV-GP vaccine (also known as VSV-EBOV or ERVEBO®).
Patients who are unable to receive a booster shot of the vaccine at 6 months.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Bdzyfaoapfivamecxqfnulx Fnbq Thzelclvoxqvd	Hamburg	Germany
Gasbst Ufadwtvubs Frlchzemi	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.02.2025

Trial locations

ERVEBO® is a vaccine designed to protect people from the Ebola virus. It works by helping the body build up its defense system, known as the immune system, to fight off the virus if a person is exposed to it. In this clinical trial, researchers are studying how well the vaccine works over time and whether giving an extra dose, called a booster, can help maintain or improve the body’s immune response. The goal is to see if the booster dose can provide better protection for people who might come into contact with the Ebola virus because of their job.

Investigated diseases:

Ebola disease

Ebola virus infection – Ebola virus infection is a severe viral illness caused by the Ebola virus. It begins with symptoms such as fever, fatigue, muscle pain, and headache. As the disease progresses, individuals may experience vomiting, diarrhea, rash, and impaired kidney and liver function. In some cases, internal and external bleeding can occur. The virus spreads through direct contact with bodily fluids of infected individuals or contaminated surfaces. The progression of the disease can vary, with some individuals recovering while others may experience more severe symptoms.

Trial ID:

2024-517352-35-00

Protocol code:

Prepare-Germany

NCT ID:

NCT05959421

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Long-Term Immunity of the Ebola Vaccine VSV-EBOV and Booster Dose for Workers at Risk of Ebola Exposure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?