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Study Comparing Intradermal and Intramuscular Rabies Vaccine Doses in Adults

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the disease known as rabies, a serious viral infection that affects the brain. The study will use a vaccine called Rabipur, which contains an inactivated form of the rabies virus, specifically the strain known as Flury LEP. The purpose of the study is to compare the effectiveness of two different ways of giving this vaccine to adults: one method involves injecting it into the muscle, known as intramuscular injection, and the other involves injecting it just under the skin, known as intradermal injection.

Participants in the study will receive the vaccine in one of these two ways during a single visit. The study will then monitor the participants to see how well their bodies respond to the vaccine by measuring the level of protective antibodies against rabies in their blood. These antibodies are proteins made by the immune system to help fight infections. The study will check these levels at different times after the vaccination to see how well the vaccine works over time.

The study aims to determine if the new methods of giving the vaccine are as effective as the standard method currently used. This will be assessed by looking at how many participants have enough antibodies to protect against rabies after receiving a booster dose of the vaccine. The study will also look at the safety of the vaccine when given in these new ways, ensuring that it does not cause any unexpected side effects. The trial is expected to continue until 2025, with the goal of improving rabies prevention strategies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age (18 to 60 years), residency in Belgium, and willingness to follow the study schedule.

    You will be asked to provide written informed consent, which means you agree to participate in the study after understanding all the details.

  2. Step 2

    Vaccination

    You will receive a rabies vaccine. The vaccine is given as an intramuscular injection, which means it is injected into a muscle.

    The dosage for this vaccine is 1 x 1.0 mL and it is administered in a single visit.

  3. Step 3

    Follow-up visits

    After the vaccination, you will have follow-up visits to monitor your body's response to the vaccine.

    These visits will include tests to measure the level of rabies antibodies in your blood. The goal is to ensure that the antibody levels are at or above a certain threshold, which indicates a successful immune response.

  4. Step 4

    Booster dose

    A booster dose may be administered to enhance your immune response. This is a common practice to ensure long-lasting protection.

    The effectiveness of the booster will be assessed by measuring antibody levels seven days after the booster dose.

  5. Step 5

    Final assessment

    The final assessment will occur at the end of the study period. This will include a comprehensive evaluation of your immune response to the vaccine.

    The study aims to determine if the new vaccination schedule is as effective as the standard schedule in producing a strong immune response.

Who can join the trial?

5 criteria

  • Must be between 18 to 60 years old at the time of joining the study.
  • Must be willing to provide written informed consent. This means you agree to participate after being fully informed about the study.
  • Must be a permanent resident of Belgium during the study period.
  • Must be prepared to follow the study schedule, which includes attending all required appointments and procedures.
  • Women who can have children must be willing to use contraception for 1 month after each vaccination to prevent pregnancy.

Who cannot join the trial?

8 criteria

  • Participants who have had a severe allergic reaction to any component of the rabies vaccine cannot join the study. A severe allergic reaction is a serious response by the body to a substance, which can cause symptoms like difficulty breathing or swelling.
  • Individuals with a weakened immune system are not eligible. A weakened immune system means the body's defense against infections is not working properly, which can happen due to certain illnesses or medications.
  • People who are currently participating in another clinical trial are excluded. This is to ensure that the results of this study are not affected by other treatments.
  • Pregnant or breastfeeding women cannot participate. This is to protect the health of the mother and the baby.
  • Anyone with a history of rabies vaccination within the past year is not eligible. This is to ensure that the study measures the effects of the vaccine accurately.
  • Individuals with a history of rabies infection are excluded. This is because their immune response might be different from those who have never had rabies.
  • Participants who have received blood products or immunoglobulins in the past three months cannot join. These substances can affect how the body responds to the vaccine.
  • People with any condition that the study doctors believe would make participation unsafe or affect the study results are not eligible. This is to ensure the safety of all participants and the integrity of the study.
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Investigated drugs

Purified Chick-Embryo Cell-Culture Rabies Vaccine is a type of vaccine used to protect people from rabies, a serious disease caused by a virus that affects the brain. This vaccine is made using cells from chick embryos, which are used to grow the virus in a safe way. Once the virus is grown, it is killed and purified to make the vaccine. The vaccine helps your body build up defenses, or antibodies, against the rabies virus, so if you are ever exposed to the virus, your body can fight it off more effectively. In this trial, the vaccine is being tested to see if it works just as well when given in different ways, either under the skin or into the muscle, compared to the usual method.

What is already known about the treatment

Purified Chick-Embryo Cell-Culture Rabies Vaccine – This vaccine is administered either intradermally (into the skin) or intramuscularly (into the muscle) to protect against rabies, a serious viral infection. It is currently being studied in a clinical trial to compare its effectiveness and safety with standard rabies vaccination methods. The vaccine works by stimulating the body's immune system to produce antibodies that can fight the rabies virus. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Rabies – Rabies is a viral disease that affects the central nervous system. It is primarily transmitted through the bite of an infected animal. The virus travels from the site of the bite through the nerves to the brain. Initial symptoms may include fever, headache, and general weakness. As the disease progresses, neurological symptoms such as anxiety, confusion, and agitation may develop. Eventually, the disease can lead to severe neurological impairment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511506-22-00Estimated enrolment360 patientsSponsorInstitute Of Tropical Medicine

sourced from the EU Clinical Trials Register and site verification

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