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Rabies Prophylaxis in Healthy Volunteers After Rabies Virus (Inactivated) Strain Flury LEP Vaccination

Verified siteRegistered 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 being done in healthy volunteers to study rabies protection. It compares three different vaccination plans given before possible exposure to rabies: a two-visit intramuscular plan, a two-visit intradermal plan, and a one-visit intradermal plan. The vaccine used is Rabipur, which contains rabies virus (inactivated) strain Flury LEP. The purpose of the study is to see how well these earlier vaccination plans can be boosted by a single extra vaccine dose given at least five years later.

In the study, participants receive one booster dose of the vaccine in the muscle. The study then follows how the body responds over the next days after the booster. Blood samples are taken during the study to check for signs of protection, and any side effects such as pain, redness, swelling, headache, fever, or tiredness are recorded. The study compares the three earlier vaccination plans to see which one gives a strong response after the booster.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Trial entry and study group assignment

    After joining the study, you are placed into one of three rabies vaccination schedules. The study compares three ways of giving a vaccine before possible exposure to rabies. These schedules are called two-visit intramuscular, two-visit intradermal, and one-visit intradermal.

    The vaccine used is Rabipur, which contains inactivated rabies virus. Inactivated means the virus cannot cause rabies. Intramuscular means the injection is given into a muscle. Intradermal means the injection is given into the skin.

  2. Step 2

    Vaccination phase

    You receive a single 1 ml dose of Rabipur as a booster vaccination by intramuscular injection at least 5 years after your earlier rabies vaccination schedule.

    The study description states that this booster is given as a simulated post-exposure prophylaxis. This means the vaccination is given in a way that imitates treatment after possible exposure to rabies, even though the study is testing the response to the booster rather than treating a real exposure.

    The booster vaccination is given once, on Day 0.

  3. Step 3

    Blood test on the day of booster

    On Day 0, you have a blood test to measure your starting level of protection before the booster is assessed.

    The study uses a laboratory test called RFFIT, which stands for Rapid Fluorescent Focus Inhibition Test. This test measures how well your blood can block the rabies virus in the laboratory.

    The study checks whether your RFFIT level is at least 0.5 IU/mL. IU/mL means international units per millilitre, which is a way to measure the amount of antibody protection in the blood.

  4. Step 4

    Follow-up blood test on day 7

    On Day 7 after the booster, you have another blood test.

    This visit checks whether your immune response has increased enough after the vaccine. The main study result is whether your RFFIT level is at least 0.5 IU/mL on this day.

    The study also checks whether your RFFIT level is at least 3.0 IU/mL and at least 10 IU/mL on Day 7.

  5. Step 5

    Follow-up blood test on day 14

    On Day 14 after the booster, you have another blood test.

    This visit checks whether your RFFIT level is at least 0.5 IU/mL on this day.

    The study also checks whether your RFFIT level is at least 3.0 IU/mL and at least 10 IU/mL on Day 14.

  6. Step 6

    Safety checks during the study

    During the study period after the booster vaccination, you are assessed for side effects. The study records swelling, pain, redness, headache, fever, and fatigue.

    The study also records any other unwanted medical events, including unwanted reactions where the vaccine was given.

    The study records any serious adverse events. A serious adverse event is a serious medical problem that occurs during the study period.

  7. Step 7

    Study end

    The study ends after the follow-up assessments are completed, including the blood tests on Day 7 and Day 14 after the booster.

    The study period runs within the overall trial timeframe from 2026-05-15 to 2027-06-15.

Who can join the trial?

4 criteria

  • Be 18 to 60 years old at the time of joining the study.
  • Be willing and able to give written informed consent, which means signing a form to show you understand the study and agree to take part.
  • Have previously received a rabies vaccine using one of these schedules: 2x1 intramuscular (IM), 2²ID intradermal, or 1²ID intradermal.
  • Have received that rabies vaccination at least 5 years before the study starts.

Who cannot join the trial?

7 criteria

  • Known allergy to any component of the vaccines, meaning an ingredient used in the vaccine.
  • Currently taking, or having taken within the past 3 months (12 weeks), immunomodulating drugs, which are medicines that change how the immune system works.
  • Planned vaccination with any inactivated vaccine within 2 weeks before or after the study vaccinations, or with any live attenuated vaccine within 1 month before or after the study vaccinations. An inactivated vaccine uses killed germs, and a live attenuated vaccine uses weakened germs.
  • Being pregnant during the study vaccination day, or having an active wish to become pregnant at that time.
  • Having had a pre-exposure rabies vaccination schedule that is different from the ones allowed in the study. Pre-exposure vaccination means rabies vaccination given before any possible exposure to the virus.
  • Having had a rabies booster vaccination before. A booster is an extra vaccine dose given after the first vaccination series.
  • Being unable or unwilling to follow the study rules and procedures.
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Investigated drugs

  • Rabipur

    is a rabies vaccine made from inactive rabies virus. In this trial, it is given as a single injection into a muscle to see how well it boosts the body’s protection against rabies after earlier vaccination. It is being used to test whether one booster dose can quickly raise immunity years after the first rabies prevention shots.

  • Intradermal vaccination regimen

    is a way of giving the rabies vaccine into the skin instead of into a muscle. In this trial, it is one of the earlier rabies prevention schedules being studied to see how well it prepares the immune system for a later booster dose.

  • Intramuscular vaccination regimen

    is a way of giving the rabies vaccine into a muscle. In this trial, it is one of the earlier rabies prevention schedules being studied to see whether it can lead to a strong response when a booster dose is given years later.

What is already known about the treatment

Rabipur - Rabipur is an inactivated rabies vaccine given as an injection into a muscle, usually in the arm. It is an established medicine in medical use and is well described in medical literature for preventing rabies after exposure and for pre-exposure protection in people at risk. It works by exposing the immune system to a harmless, inactivated form of the rabies virus so the body can make protective antibodies; it is classified as a viral vaccine, specifically an inactivated whole-virus vaccine.

Investigated diseases

Rabies - Rabies is a viral disease that affects the nervous system and is usually spread through the bite or scratch of an infected animal. It begins with vague symptoms such as fever, weakness, or tingling at the site of exposure, then can progress to agitation, confusion, trouble swallowing, and muscle spasms. As the illness advances, the nervous system becomes increasingly affected, leading to severe brain and nerve dysfunction.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524765-24-00Protocol codeBAZOOKA_221Estimated enrolment561 patientsSponsorInstitute Of Tropical Medicine

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