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Ervebo is a live, attenuated viral vaccine. Its full name is Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live). The vaccine is built from a recombinant vesicular stomatitis virus (rVSV) of the Indiana strain, in which the VSV envelope glycoprotein has been deleted and replaced with the surface glycoprotein of the Zaire Ebola virus (Kikwit 1995 strain).[2] The vaccine is produced in Vero cells and contains genetically modified organisms.[2] Ervebo is an authorised medicine indicated for active immunisation of individuals 1 year of age or older against Ebola virus disease caused by the Zaire Ebola virus.[2]
Ervebo uses a recombinant vesicular stomatitis virus as a delivery vehicle. The gene for the VSV envelope glycoprotein is removed and replaced with the gene for the Zaire Ebola virus surface glycoprotein.[2] When the vaccine is injected, the modified virus expresses the Ebola glycoprotein on its surface. This exposes the immune system to an Ebola virus protein without causing Ebola disease, allowing the body to build an immune response that can recognise the real virus.
Ervebo is a solution for injection. It is given as a single 1 mL dose by intramuscular injection, preferably into the deltoid area of the non-dominant arm or the higher anterolateral area of the thigh.[2] The vaccine should not be injected intravascularly, and no data are available for subcutaneous or intradermal administration.[2] The injection site must be covered with a bandage to provide a physical barrier.[2]
One registered Phase 4 trial, PREPARE-Germany, studied the durability of immunity induced by Ervebo and the effect of a booster dose.[1] The trial enrolled 70 participants at potential occupational risk for Ebolavirus exposure and has been completed.[1]
The study compared the immune response 24 months after primary vaccination with Ervebo alone against primary vaccination followed by a homologous booster dose at month 6.[1] The primary outcomes were the course of binding anti-EBOV antibody titers and anti-EBOV neutralizing antibody titers during 24 months after primary vaccination, as well as titers at 12 and 24 months of follow-up.[1]
The product information states that the safety, immunogenicity and efficacy of Ervebo have not been established in children aged less than 1 year.[2] A Phase 3 randomised, double-blind, placebo-controlled study in healthy adults evaluated the extended safety of the vaccine.[3] Detailed side-effect data from that study are not included in the available source material.
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