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Borrelia Burgdorferi, serotype 3, outer surface protein A fused via a linker to Borrelia Burgdorferi, serotype 4, outer surface protein A is a protein-based investigational vaccine substance. It is studied as part of VLA15, a 6-valent OspA-based Lyme disease vaccine.[1] The substance is not an authorised medicine; it is still investigational. It is a protein-based substance, not a chemical one. The full name describes two outer surface protein A (OspA) fragments from two different serotypes of Borrelia Burgdorferi, joined together by a linker.
The substance is designed to trigger an immune response against outer surface protein A (OspA), a protein found on the surface of Borrelia bacteria that cause Lyme disease. By exposing the immune system to OspA fragments, the vaccine aims to teach the body to recognise and fight the bacteria before an infection can establish itself. The trial measured anti-OspA quantitative immunological assay titer as a primary immunogenicity outcome.[1]
The vaccine is given as a 0.5 millilitre solution for injection, administered by intramuscular use.[1] The trial also used a sodium chloride solution 0.9% as a placebo comparator, given by intramuscular injection.[1]
One Phase 3 trial (NCT05477524) has been completed.[1] The trial enrolled 9,400 participants and was placebo-controlled.[1] It aimed to demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose.[1]
The primary efficacy outcome was clinically and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato, as determined by the adjudication committee.[1] Primary safety outcomes included local reactions such as pain at the injection site, redness, and swelling, as well as systemic events like fever, headache, fatigue, muscle pain, and joint pain.[1] Adverse events, newly diagnosed chronic medical conditions, and serious adverse events were also recorded.[1] Primary immunogenicity outcomes included anti-OspA quantitative immunological assay titer, with the aim of demonstrating that immune responses to the 6 serotypes induced by VLA15 are equivalent across 3 independent lots, and that immune responses in children 5–17 years of age are noninferior to those in adults 18–44 years of age after the booster dose.[1]
The trial included children aged 5–17 years and adults aged 18–44 years, as the immunogenicity comparison was made between these two age groups.[1]
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