Journal Article

Non-inferiority and vaccine titer-confirmation studies of MMR vaccine (JVC-001; measles AIK-C, mumps RIT4385, and rubella Takahashi strains) in healthy 1-year-old Japanese children

Kawamura, Asuka, Kimata, Motoshi, Nakayama, Tetsuo, Hamada, Shunsuke, Oe, Keiji, Sakakibara, Sachiko, Sogawa, Yoshitaka, Nakatsu, Takafumi

2025

Overview

JVC-001 is a new live attenuated measles–mumps–rubella vaccine (measles AIK-C, mumps RIT4385, and rubella Takahashi strains). Two phase 3 studies were conducted, one to verify the non-inferior immunogenicity of JVC-001 versus the approved mumps and measles–rubella vaccines (J301 study) and another to compare the immunogenicity and safety of different titers (J302 study). Both studies were multicenter, randomized, observer-blinded, phase 3 studies. J301 compared the immunogenicity elicited with a single dose of JVC-001 or control vaccines (measles–rubella vaccine + mumps vaccine [Hoshino strain]). J302 was a titer-confirmation study of a single dose of a low- or high-titer formulation of JVC-001. Both studies enrolled healthy Japanese children (aged 1 year) and had a primary efficacy endpoint of seropositive rate on Day 43. Overall, 861 participants completed J301 (JVC-001, n = 429; control, n = 432) and 100 participants completed J302 (low-titer, n = 48; high-titer, n = 52). For measles and rubella virus antibody titer, non-inferiority of JVC-001 was demonstrated: seropositive rates were ≥ 99.5 %. For mumps virus genotype D antibody titer, seropositive rates were 80.6 % (95 % confidence interval 76.5 % to 84.4 %) with JVC-001 and 88.1 % (84.6 % to 91.0 %) with control vaccination. Thus, non-inferiority for mumps virus genotype D antibody titer was not confirmed. Seropositive rates were similar in the low- and high-titer groups. There were no events leading to discontinuation, or cases of aseptic meningitis in either study. Although the non-inferiority of JVC-001 to currently approved vaccines was not demonstrated for the mumps component, clinical significance and consistent efficacy were indicated. Vaccine titer did not affect immunogenicity. JVC-001 is expected to have a lower risk of aseptic meningitis to currently approved vaccines and raised no new safety signals emerged. •JVC-001 is a new MMR vaccine (measles: AIK-C, mumps: RIT4385, rubella: Takahashi).•Comparative clinical trial of JVC-001 was conducted using MR and mumps vaccines.•Non-inferiority of immunogenicity was not demonstrated only against mumps virus.•However, clinical significance and consistent efficacy were indicated for JVC-001.•Different virus doses of JVC-001 did not affect immunogenicity and safety profile.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Allergy and Immunology / Antibodies / Antibodies, Viral - blood / Aseptic meningitis / Body temperature / Childhood / Clinical trials / confidence interval / Consent / East Asian People / Effectiveness / Female / genotype / Genotype & phenotype / Genotypes / Hearing loss / Humans / Immunization / Immunogenicity / Immunogenicity, Vaccine / Infant / Japan / live vaccines / Male / Measles / Measles - prevention & control / Measles-Mumps-Rubella Vaccine - administration & dosage / Measles-Mumps-Rubella Vaccine - adverse effects / Measles-Mumps-Rubella Vaccine - immunology / Measles–mumps–rubella vaccine / Meningitis / Mumps / Mumps - immunology / Mumps - prevention & control / Mumps orthorubulavirus / Mumps virus - immunology / Mumps virus genotype G / Neutralizing antibody / risk / RIT4385 strain / Rubella / Rubella - immunology / Rubella - prevention & control / Rubella virus / Rubella virus - immunology / seroprevalence / Strains (organisms) / Vaccination / Vaccines / Vaccines, Attenuated - administration & dosage / Vaccines, Attenuated - adverse effects / Vaccines, Attenuated - immunology / Viruses