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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Lfgrn Ulyddquavdzo Mwctpsx Cpupiub (nbuvt	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	10.01.2022

Trial locations

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.

Investigated diseases:

Rabies

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 ID:

2023-510480-35-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?