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Study of Single-Dose Rabies Vaccine (Inactivated Flury LEP Strain) Immunity After Five Years: Testing Booster Response in Previously Vaccinated Adults

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What is this trial about?

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

This study focuses on rabies virus prevention using Rabipur, an inactive vaccine given through intramuscular injection. The vaccine contains an inactivated rabies virus strain Flury LEP and is being studied to evaluate long-term protection against viral infections.

The purpose is to assess how well the body's immune system remembers and responds to the rabies vaccine five years after receiving a single dose. The study involves comparing the effectiveness of a single-dose vaccination approach to a traditional two-dose vaccination schedule. Participants will receive vaccine injections and have their blood tested to measure their immune response.

The study will track participants over a five-year period. During this time, participants will receive either a single dose or two doses of the vaccine initially, followed by additional doses after five years to simulate an exposure situation. The immune system's response will be measured through blood tests that look for protective antibodies against the rabies virus.

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 vaccination

    You will receive a single intramuscular injection of 1.0 mL of rabies vaccine.

    This injection contains an inactive form of the rabies virus that helps your body develop protection against rabies.

  2. Step 2

    First follow-up period

    After 57-64 days from the initial vaccination, your blood will be tested to measure the level of protective antibodies.

    This test checks how well your body has responded to the vaccine.

  3. Step 3

    Annual check-ups

    You will need to visit for blood tests at the following intervals:

    One year after initial vaccination

    Two years after initial vaccination

    Five years after initial vaccination

  4. Step 4

    Final vaccination simulation

    At the five-year mark, you will receive two additional vaccine doses to simulate a post-exposure situation.

    Blood samples will be collected on day 1 (before vaccination)

    Additional blood samples will be taken on day 8 and day 15 after these vaccinations

    These tests will measure how quickly your body responds to the vaccine after five years.

  5. Step 5

    Study completion

    The study concludes after the final blood test on day 15 of the simulation phase.

    Total duration of participation is approximately 5 years and 2 weeks.

Who can join the trial?

7 criteria

  • You must be between 18 and 40 years old
  • You must be in good general health, as determined by the study doctor
  • You must be willing and able to follow all study procedures and requirements
  • You must be able to understand and sign an informed consent document
  • You must never have been exposed to rabies or received any rabies vaccines in the past
  • You must be willing to participate in follow-up visits for 5 years
  • You should not be likely to need rabies preventive vaccination (PrEP) in the next 5 years due to work or other activities

Who cannot join the trial?

13 criteria

  • History of previous rabies vaccination within the past 5 years
  • Known allergic reactions to any component of rabies vaccines
  • Current pregnancy or planning to become pregnant during the study period
  • Active immune system disorders or conditions that weaken the immune system
  • Use of medications that suppress the immune system (immunosuppressants)
  • Received blood products or immunoglobulins (antibody preparations) in the past 3 months
  • Currently experiencing any acute illness or fever
  • History of serious adverse reactions to vaccines
  • Participation in another clinical trial within the past 30 days
  • Any condition that, in the opinion of the investigator, could interfere with the study procedures or results
  • Unable to commit to the full study schedule and follow-up visits
  • History of chronic diseases that are not well-controlled
  • Current treatment with blood thinners or medications that affect blood clotting
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Investigated drugs

  • Rabies vaccine

    This is a vaccine used to prevent rabies infection. In this trial, it's given as a pre-exposure prophylaxis (preventive measure) through intramuscular injection. The vaccine stimulates the body's immune system to produce antibodies against the rabies virus. The study examines how well the protection lasts over five years and how effectively the body responds to booster shots when needed.

  • Post-exposure prophylaxis (PEP) vaccine

    This is the same rabies vaccine but used in a different way - as a simulated post-exposure treatment. It's used in the study to test how well participants' immune systems respond to additional doses of the vaccine after the initial vaccination. This helps determine the long-term effectiveness of the initial preventive treatment.

What is already known about the treatment

Rabies Vaccine - This is an intramuscular vaccine administered as a preventive measure against rabies virus infection. The vaccine works by stimulating the immune system to produce antibodies against the rabies virus, providing protection before potential exposure to the disease. It belongs to the class of viral vaccines and is currently used in pre-exposure prophylaxis protocols, requiring precise dosing and timing for optimal effectiveness. The vaccine's mechanism of action involves triggering the production of rabies virus neutralizing antibodies (RVNA), which provide long-term immunity against potential rabies infection.

Investigated diseases

Rabies - A viral infection that affects the central nervous system, caused by the rabies virus which spreads through the saliva of infected animals. The virus travels from the site of exposure through the nerves to the brain. Initially, infected individuals may experience flu-like symptoms including fever and headache. As the disease progresses, symptoms may include anxiety, confusion, agitation, and abnormal behavior. The virus can affect both humans and animals, with transmission typically occurring through animal bites.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510480-35-00Estimated enrolment240 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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