Study on BCG Vaccine and Rabies Virus (Inactivated) for Healthy Volunteers: Exploring Pre-Vaccination Immune Status and Its Impact on Vaccine Response
- Participants:Adults · Healthy volunteers
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Rabies virus (inactivated) is a vaccine containing rabies virus that has been killed, so it cannot cause rabies.[3] The active substance is also known as rabies vaccine (inactivated) for human use, and it carries the ATC code J07BG01, which classifies it as a rabies, inactivated, whole-virus vaccine.[1] In the product records of the trial listed on this page, the substance appears under the trade name Rabipur and is described as a structurally diverse substance of vaccine origin.[1] The product records show no marketing authorisation for this specific product, and the company named as the supplier is Bavarian Nordic A/S.[1] A related inactivated rabies vaccine called VaxRabeo received a positive opinion from the European Medicines Agency (EMA) in September 2026, recommending marketing authorisation for pre-exposure and post-exposure prophylaxis against rabies in all age groups.[2] The FDA's UNII registry also lists rabies virus inactivated antigen as an ingredient substance under the UNII code C6547J35OD.[4]
After the vaccine is given, the immune system forms antibodies against the rabies virus.[3] These antibodies protect against infection or disease caused by the rabies virus.[3] The EMA describes the same mechanism for VaxRabeo: the vaccine induces the production of neutralising antibodies against the surface glycoprotein of the rabies virus.[2] The benefit of the vaccine is its ability to induce a protective antibody response in adults and children when used before or after exposure to the virus, and as a booster vaccination.[2]
The product records for the trial on this page describe the pharmaceutical form as an injection and the route of administration as intradermal injection.[1] In the trial, Rabipur is given as a 0.2 ml intradermal injection.[1] The package leaflet for Rabipur describes the product as a powder and solvent for solution for injection in a pre-filled syringe.[3] The EMA describes VaxRabeo as a powder and solvent for suspension for injection.[2]
One clinical trial is listed in the EU Clinical Trials Information System for this substance.[1] The trial, titled "(Pre-BCGvacc) BCG vaccination: can pre-vaccination immune status predict outcome?", is a low-intervention interventional study in 50 healthy volunteers.[1] In this trial, Rabipur is not the main substance under investigation; it serves as an auxiliary vaccine, while the main comparison is between BCG Vaccine AJV and BCG vaccine, freeze-dried.[1] The primary outcome is the induction of mycobacterial growth control measured in vitro by MGIA, defined as a 1 log reduction post vaccination compared to the inoculum.[1] The level of control in MGIA is used as a classifier to assess pre-vaccination functional status.[1] The trial is currently authorised, meaning it has received regulatory approval to proceed, but no results have been reported.[1]
For the related inactivated rabies vaccine VaxRabeo, the most frequently reported adverse reactions in adults were injection site pain, myalgia, headache and malaise.[2] In children, the most frequently reported adverse reactions were injection site pain or swelling, myalgia in children aged 2 years and above, and abnormal crying and irritability in children aged 12 to 23 months.[2] The package leaflet for Rabipur states that none of the components of the vaccine can cause rabies.[3] The leaflet also notes that people with a history of severe allergic reaction to the active substance or any ingredient should not receive the vaccine before possible exposure to rabies, although after exposure the seriousness of rabies means the vaccine can be given to anyone, including pregnant women.[3]
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