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Purpose: This Phase III, multicenter, open-label, single-arm study evaluated the safety and immunogenicity of the measles-mumps-rubella (MMR) combined vaccine, JVC-001, as a second MMR vaccination., Methods: Healthy Japanese children aged 5-6 years received a single dose of JVC-001 following a first measles, mumps, and rubella vaccination (measles-rubella bivalent and mumps monovalent vaccine [Hoshino or Torii strain] or JVC-001) or the MMR vaccine received between ages 1 to <4 years. Immunogenicity was evaluated using antibody titers before and after vaccination (Day 1/Day 43). The primary endpoint was the seroprotection rate of antibody titers against each virus; geometric mean titer (GMT) was also evaluated. Adverse events (AEs) and adverse drug reactions (ADRs) were monitored., Results: One-hundred participants completed the study. The seroprotection rate of antibody titers against measles, rubella, and mumps virus (genotype D) were 100.0 % (95 % confidence interval [CI] 96.4 %, 100.0 %), 100.0 % (95 % CI 96.4 %, 100.0 %), and 100.0 % (95 % CI 96.3 %, 100.0 %), respectively. GMT (fold) increases (Day 1 to Day 43) were 16.0 to 55.7 for measles virus, 35.5 to 99.0 for rubella virus, and 25.7 to 89.5 for mumps virus (genotype D). Solicited ADRs occurred in 40.0 % of participants (injection site, 34.0 %; systemic, 13.0 %)., Conclusions: The second MMR vaccination with JVC-001 demonstrated sufficient antibody coverage against all three viruses; the safety profile was tolerable., Clinical Trial Registration: jRCT2080225022., Competing Interests: Declaration of competing interest Tetsuo Nakayama received consultant fees from Daiichi Sankyo Co., Ltd.; scholarship research funding from Eiken Chemical Co., Ltd.; lecture fees from Takeda Pharmaceutical Co., Ltd., MSD K.K., and Meiji Seika Pharma Co., Ltd.; honoraria for attending the meeting from Nitta Gelatin Inc.; fees for lecture and manuscript writing from GlaxoSmithKline K·K.; was honorary member of the Japanese Society for Vaccinology; secretary of the General Affairs Department of the Japanese Society of Clinical Virology; delegates of the Japanese Association for Infectious Diseases and the Japanese Society for Virology. Asuka Kawamura, Yoshitaka Sogawa, Sachiko Sakakibara, Takafumi Nakatsu, Motoshi Kimata, and Keiji Oe are employees of Daiichi Sankyo Co., Ltd., (Copyright © 2024 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control. Published by Elsevier Ltd. All rights reserved.)

Background: The measles-mumps-rubella vaccine was withdrawn from the National Immunization Program in 1993 because aseptic meningitis was reported as a post-vaccination adverse reaction in Japan. This study aimed to measure the uptake of and determinants influencing mumps vaccination, including concerns about adverse reactions., Methods: We conducted this cross-sectional survey for all parents whose children underwent 18-month health checkups in Kanazawa City between October 2019 and February 2020. Community nurses interviewed the parents using a unified questionnaire, and 1422 parents responded., Results: Based on records from maternal and child health handbooks, the mumps vaccination rate was 55.6%. The most common reason for parents not vaccinating their children against mumps was that "it is not a routine vaccine" (35.9%), whereas "concern about adverse reactions" accounted for only 2.2%. In multivariate analysis, the significantly positive factors associated with vaccination against mumps were children whose parents knew that adverse reactions were fever, rash, diarrhea, and vomiting; had received a recommendation for vaccination from their family members; had read the Vaccination Guide issued by the city; vaccinated with other voluntary vaccines or treated for gastroenteritis; and had a deep general understanding of vaccination. Conversely, the significantly negative factor was children whose parents had not received any recommendation for vaccination., Conclusion: The mumps vaccination rate could be improved by adding the mumps vaccine in the routine vaccination program and educating parents by disseminating correct information on mumps and the mumps vaccine, and by primary care physicians routinely recommending vaccination., Competing Interests: Declaration of Competing Interest Takashi Nakano receives lecture fees from Daiichi Sankyo Co., Ltd., Sanofi Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The domestic combined measles-mumps-rubella (MMR) vaccine was withdrawn in Japan in 1993 following an outbreak of aseptic meningitis attributed to the mumps component of the cocktail. KM-248 is an MMR vaccine (M-M-R ® II), manufactured by Merck & Co., Inc. (Kenilworth, NJ, USA) and registered and approved in 74 countries, but which has not been approved in Japan. This multicenter, randomized, single-blind study, was designed to evaluate the noninferiority of the KM-248 measles component in terms of immunogenicity when compared to the control measles vaccine already approved in Japan and the seroconversion rates for these three viruses following KM-248 administration. Vaccination with KM-248 in children aged 12-90 months (n = 178) induced robust immune responses to measles, mumps, and rubella viruses. The seroconversion rate for the measles virus by the measles component of KM-248 (n = 172) was shown to be non-inferior to that of the control measles vaccine (n = 85). No serious adverse reactions, such as aseptic meningitis or anaphylaxis, were observed. Fever is one of the most common adverse reactions associated with vaccination and was observed in approximately half of the participants. KM-248 administered to healthy Japanese children aged between 12 and 90 months demonstrated a comparable safety and efficacy profile to the control vaccine.

Susceptible healthcare personnel (HCP) are at high risk for acquiring and transmitting measles, mumps, rubella, and varicella (MMRV). Presumptive evidence of immunity to MMRV is recommended for HCP. The aim of this investigation was to examine the seroprevalence of MMRV in Japanese HCP and the association with history or vaccination in terms of occupational safety. To improve infection control at our hospital, we also assessed their immune status by implementing prevaccination antibody screening and an immunization program with postvaccination serological testing. We implemented seroprevalence surveys on MMRV antibodies among 243 newly and 2,664 previously hired HCP in a Japanese tertiary care hospital. Self-administered questionnaires about history of MMRV and vaccination with or without written documentation were completed for newly hired HCP. Prevaccination and postvaccination serological tests were performed using virus-specific IgG enzyme-linked immunosorbent assays. Indeed, only a few HCP accurately remembered or had written records of their disease or vaccination history. After our immunization program was implemented, the seropositivity rate reached levels as high as ~98% for measles, rubella, and varicella, and increased to ~80% for mumps. Our program was cost-effective, and no severe adverse reactions were reported. The prevaccination antibody screening for HCP would be helpful, given the lack of written vaccination records or documented disease history, and is also useful for the prevention of adverse reactions associated with unnecessary vaccination. It is important for infection control practitioners to comprehend the immune status of HCP against MMRV, and then provide an appropriate immunization program for susceptible HCP.

The measles elimination project led by the World Health Organization (WHO) has been moving toward the target of eliminating measles in the WHO Western Pacific Region. In Japan, prefectural public health institutes play a key role for the laboratory diagnosis of measles virus (MV) infection, which is based on PCR, virus isolation, and genotyping. Microscopic examination of viral-sensitive cell lines during routine virus isolation from nasopharyngeal specimens has been used to detect the morphological changes typical for the growth of respiratory viruses. Here, we describe the unexpected isolation of vaccine-derived MVs from the two unrelated 1-year-old boys with acute respiratory infection. The nasopharyngeal specimens were obtained from one patient in February 2007 and from another in December 2012. Incidentally, the two children had received measles-rubella vaccination 9 or 11 days before the sampling. The isolates from two children induced morphological changes of the viral-sensitive cell lines, such as syncythia formation (cell fusion). We finally identified the isolates as vaccine-derived MVs by sequence analysis and immunological methods with anti-measles nucleoprotein antibodies. As no typical symptoms of MV infection were observed in either patient, the vaccine-derived MVs were isolated not as causative pathogens but by chance. In fact, there was no suspected case of secondary MV infection in either patient, thereby excluding the possibility that vaccine-derived MVs spread from human to human. Our experiences suggest the possibility of vaccine-derived MV isolation by cell cultures and the difficulty in identifying MVs in specimens from patients other than clinically suspected measles cases.

Objective: The aim of this study was to investigate the relationship between autism spectrum disorder (ASD) and general vaccinations, including measles-mumps-rubella (MMR) vaccine, in Japanese subjects, a population with high genetic homogeneity., Patients and Methods: A case-control study was performed. Cases (n=189) were diagnosed with ASD, while controls (n=224) were volunteers from general schools, matched by sex and birth year to cases. Vaccination history and prenatal, perinatal, and neonatal factors from the Maternal and Child Health handbook, which was part of each subject's file, were examined. To determine the relationship between potential risk factors and ASD, crude odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated, and the differences in mean values of the quantitative variables between cases and controls were analyzed using an unpaired t-test. Moreover, MMR vaccination and the effect of the number of vaccine injections were investigated using a conditional multiple regression model., Results: For MMR vaccination, the OR was 1.04 (95% CI, 0.65-1.68), and no significant differences were found for the other vaccines. For all of the prenatal, perinatal and neonatal factors, there were no significant differences between cases and controls. Furthermore, regarding the presence of ASD, MMR vaccination and the number of vaccine injections had ORs of 1.10 (95% CI, 0.64-1.90) and 1.10 (95% CI, 0.95-1.26), respectively, in the conditional multiple regression model; no significant differences were found., Conclusions: In this study, there were not any convincing evidences that MMR vaccination and increasing the number of vaccine injections were associated with an increased risk of ASD in a genetically homogeneous population. Therefore, these findings indicate that there is no basis for avoiding vaccination out of concern for ASD., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

In the present study, to elucidate an outbreak of measles in Saitama City, Japan, we analyzed the data for all notified subjects with measles. According to an active surveillance program, a total of 464 subjects were notified in 2007. The clinical criteria for the diagnosis of measles were defined as at least 3 days of a generalized maculopapular rash; a fever of 38.0 degrees C or more; and cough, mucus, or pharyngitis. Two peaks according to age group were recognized: namely, children less than 2 years of age and adolescents from 15 to 19 years of age. The latter peak was associated with the period of time when the measles-mumps-rubella vaccine had become a social problem (40.9% of vaccinees and 41.6% of non-vaccinees in this group). Japan is said to be a developing country regarding its measles vaccination strategy. In addition, no national program against measles has yet been established. Continuous efforts to increase immunization coverage are needed to interrupt indigenous measles transmission. The Japanese Ministry of Health, Labor and Welfare should therefore plan and implement a nationwide program to eliminate measles in Japan.

This study explored the safety concerns associated with combination vaccines in Japan. The impact of Japan's decision in 1975 to withdraw the combined diptheria, tetanus, and pertussis (DTP) vaccine, and then in 1993, the combined measles, mumps, and rubella (MMR) vaccine and provide only the single antigen vaccines was analyzed. Interviews with both governmental and non-governmental agency officials in Japan demonstrated that withdrawal of the DTP and MMR vaccines had significant impact on the rates of immunization and disease despite the availability of monovalent vaccines.

For decades after Kanner's original paper on the subject was published in 1943, autism was generally considered to be a rare condition with a prevalence of around 2-4 per 10,000 children. Then, studies carried out in the late 1990s and the present century reported annual rises in incidence of autism in pre-school children, based on age of diagnosis, and increases in the age-specific prevalence rates in children. Prevalence rates of up to 60 per 10,000 for autism and even more for the whole autistic spectrum were reported. Reasons for these increases are discussed. They include changes in diagnostic criteria, development of the concept of the wide autistic spectrum, different methods used in studies, growing awareness and knowledge among parents and professional workers and the development of specialist services, as well as the possibility of a true increase in numbers. Various environmental causes for a genuine rise in incidence have been suggested, including the triple vaccine for measles, mumps and rubella (MMR]. Not one of the possible environmental causes, including MMR, has been confirmed by independent scientific investigation, whereas there is strong evidence that complex genetic factors play a major role in etiology. The evidence suggests that the majority, if not all, of the reported rise in incidence and prevalence is due to changes in diagnostic criteria and increasing awareness and recognition of autistic spectrum disorders. Whether there is also a genuine rise in incidence remains an open question., (Copyright 2002 Wiley-Liss, Inc.)