V350A: An Investigational Epstein-Barr Virus Vaccine Candidate – Development Status and Clinical Evaluation

1. Executive Summary

V350A is an investigational prophylactic vaccine candidate designed to protect against Epstein-Barr Virus (EBV) infection and its associated diseases. This vaccine is being co-developed by Merck Sharp & Dohme LLC (Merck) and ModeX Therapeutics, an OPKO Health company.[1] V350A is a component of the broader MDX2201 vaccine program, which employs an innovative ferritin nanoparticle platform technology. This platform is engineered to present multiple EBV antigens—specifically glycoprotein 350 (gp350), glycoprotein H (gH), glycoprotein L (gL), and glycoprotein 42 (gp42)—to the immune system, with the objective of eliciting a robust and broadly neutralizing antibody response.[3]

Currently, V350A, alongside a related candidate designated V350B, is undergoing Phase 1 clinical evaluation in trial NCT06655324. This study aims to assess the safety, tolerability, and immunogenicity of the vaccine candidates in healthy adult volunteers.[6] The development of an effective EBV vaccine is a significant undertaking, driven by the substantial unmet medical need stemming from EBV's widespread prevalence and its etiological links to infectious mononucleosis, various malignancies (including B cell lymphomas and nasopharyngeal carcinoma), and autoimmune diseases such as multiple sclerosis.[2] At present, no approved vaccine against EBV exists.[2]