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Tick-borne encephalitis virus neudoerfl strain is the active substance in a vaccine against tick-borne encephalitis (TBE). The full registry name is Tick-borne encephalitis virus neudoerfl strain adsorbed on aluminium hydroxide, hydrated produced in chick embryo cells. It is a whole inactivated virus vaccine, meaning the virus has been killed so it cannot cause disease but can still trigger an immune response.[1] The vaccine is authorised as a medicine in Sweden, where it is sold under the name FSME-IMMUN Vuxen.[1] The authorisation holder is Pfizer AB.[1] The virus is called an arbovirus because it is transmitted by arthropods, specifically ticks.[3]
The vaccine works by exposing the immune system to the inactivated tick-borne encephalitis virus. This exposure teaches the body to recognise the virus and to produce antibodies and T-cells that can fight it off if a person is later bitten by an infected tick.[1] The new trial is measuring both T-cell responses and antibody levels to understand how the immune system responds to vaccination and to natural infection.[1] The virus itself causes tick-borne encephalitis, a disease of the brain and central nervous system that is considered one of the most important viral infections transmitted by ticks in Europe and Asia.[3]
The vaccine is given as a suspension for injection into the muscle (intramuscular injection).[1] In the clinical trial, the vaccine is provided in a pre-filled syringe containing 0.5 millilitres of suspension.[1] The product record also mentions a fixed combination product containing the substance.[1]
One Phase 3 clinical trial is authorised for this vaccine.[1] The trial, called CRA-TBE, is an interventional study with 100 participants.[1] It is measuring the magnitude and durability of T-cell responses against the tick-borne encephalitis virus using a novel rapid release assay, and comparing these with antibody responses measured by commercially available tests.[1] The trial includes several groups: patients hospitalised for TBE, patients previously hospitalised for TBE at least 6 months before enrolment, healthy or immunosuppressed people starting vaccination, and healthy or immunosuppressed people who have already been vaccinated.[1] The vaccine FSME-IMMUN Vuxen is the test product, while Encepur is included as a comparator vaccine.[1] The trial is currently in the authorised status, meaning it has been approved to proceed.[1]
Post-marketing experience with newer TBE vaccine formulations, including those without protein-derived stabilisers, shows that the majority of transient reactions after vaccination are mild.[2] Data from eight clinical trials involving approximately 7,500 subjects aged 1 to 77 years showed the expected rate of local and systemic reactions, and pharmacovigilance data from 18 countries confirmed a high level of safety with only a common range of side effects already noted for licensed TBE vaccines.[2] After distribution of more than five million vaccine doses, no potential safety risk was noted.[2]
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