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Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) is a weakened form of the mumps virus used as a vaccine component. It is part of a fixed combination product that also contains measles virus Schwarz strain, rubella virus Wistar RA 27/3 strain, and varicella virus OKA strain, all live and attenuated.[1] The substance is classified in the therapeutic area of virus diseases and is intended for the prevention of measles, mumps, rubella and varicella infections.[1] In the product records, the substance has no marketing authorisation and is considered an investigational substance.[1] The product is supplied by GlaxoSmithKline Biologicals S.A.[1]
Mumps virus RIT 4385 strain is a live, attenuated virus. Attenuated means the virus has been weakened so that it does not cause disease in healthy people but can still trigger an immune response. When given as a vaccine, the weakened virus stimulates the body to produce antibodies against mumps virus. A related FDA technology summary notes that the Jeryl Lynn-based mumps vaccine approach aims to generate a robust immune response for lasting immunity.[3] The hemagglutinin-neuraminidase (HN) and fusion (F) proteins of the mumps virus are described as major drivers of the anti-mumps virus immune response.[3]
The substance is studied for the prevention of mumps as part of a combined vaccine against four viral infections:
The European Medicines Agency (EMA) paediatric investigation plan lists the indication as prevention of measles, mumps, rubella and varicella.[2]
The substance is formulated as a suspension for injection and is given by subcutaneous use, meaning an injection under the skin.[1] In the clinical trial, the combined vaccine was administered as a 0.5 ml subcutaneous injection.[1] The EMA paediatric investigation plan also lists the pharmaceutical form as powder and solvent for solution for injection, with parenteral use as the route of administration.[2] The product is a paediatric formulation, meaning it is prepared for use in children.[1]
One completed Phase 2 interventional trial investigated the immune response and safety of the combined measles, mumps, rubella and varicella vaccine containing mumps virus RIT 4385 strain.[1] The trial enrolled 890 healthy children aged 4 to 6 years.[1] Participants received either the investigational combined vaccine or a marketed combined vaccine called ProQuad.[1]
The main goal of the trial was to evaluate the immune response in terms of antibody geometric mean concentrations (GMCs), which measure the average level of antibodies in the blood. The primary outcomes included anti-measles antibody GMCs, anti-mumps antibody GMCs, anti-rubella antibody GMCs, and anti-glycoprotein E (gE) antibody GMCs for varicella, all measured at Day 43 after vaccination.[1] The trial compared different potency formulations of the investigational vaccine to the marketed vaccine.[1]
The FDA technology summary discusses that some mumps vaccine strains have been identified as causing aseptic meningitis, a type of inflammation of the membranes around the brain and spinal cord, which led to vaccine withdrawal in some cases.[3] The summary describes a newer Jeryl Lynn-based recombinant mumps vaccine candidate engineered to reduce virulence and maintain attenuation, with the goal of avoiding aseptic meningitis.[3] No specific side effect data from the completed Phase 2 trial are provided in the available trial registry record.
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