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While the basic definition of vaccination-associated acute disseminated encephalomyelitis (ADEM) is relatively clear and easily understandable, it is often difficult to diagnose ADEM based on clinical findings alone. ADEM is actually a heterogeneous clinical syndrome that can be approximately characterized by encephalomyelitis with multiple inflammatory demyelination, autoimmune causes, and relationship with a preceding infection or vaccination. The differential diagnosis of ADEM should exclude the possibility of infectious or other autoimmune encephalitis. The occurrence of vaccination-associated ADEM is influenced by several factors including the health and ethnic status of the vaccinated individual, vaccine components, and environment. Cases suspected of vaccination-associated ADEM should be analyzed cautiously from multi-disciplinary perspectives., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Pediatric Rheumatology Association of Japan has developed evidence-based guideline of vaccination in pediatric rheumatic diseases (PRDs) as a part of Guideline of Vaccination for Pediatric Immunocompromised Hosts. Available articles on vaccination in both adult rheumatic diseases and PRDs were analyzed. Non-live vaccines are generally safe and effective in patients with PRDs on corticosteroid, immunosuppressant, and/or biologics, although efficacy may be attenuated under high dose of the drugs. On the other hand, efficacy and safety of live-attenuated vaccine for the patients on such medication have not been established. Thus, live-attenuated vaccines should be withheld and, if indicated, may be considered as a clinical trial under the approval by Institutional Review Board. All patients with PRDs anticipating treatment with immunosuppressants or biologics should be screened for infection of hepatitis B and C and tuberculosis before the commencement of medication. Varicella vaccine should be considered in sensitive patients ideally 3 weeks or longer before the commencement of immunosuppressants, corticosteroids, or biologics. Bacille Calmette-Guérin should be withheld at least for 6 months after birth, if their mothers have received anti-tumor necrosis factor-α antibodies during the second or third trimester of pregnancy.

In 2008, the number of pertussis cases increased substantially among Japanese adolescents, despite high coverage with acellular pertussis vaccine (DTaP). This study examined the effectiveness of DTaP vaccine in the routine immunization program in Japan. Between April 2009 and October 2012, we conducted a multicenter, case-control study, and compared the history of DTaP vaccination between 55 newly diagnosed pertussis cases and 90 age- and sex-matched controls. DTaP vaccine history was obtained by a self-administered questionnaire completed by their parents or guardians. Logistic regression models were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of vaccination for development of pertussis. DTaP vaccination of ≥1 dose revealed a significantly lower OR for pertussis (OR=0.20, 95%CI, 0.04-0.97), and the OR of complete vaccination (4 doses) was 0.22 (0.04-1.05). Even after limiting subjects to those whose vaccination status could be confirmed by the immunization records, the negative associations were observed. The decreasing ORs of 4-dose vaccinees remained, even among subjects who had received the fourth dose ≥9.2 years earlier (OR=0.11, 95%CI, 0.01-1.02). In conclusion, DTaP vaccination had a preventive effect for pertussis. Effectiveness was observed even 9 or more years after the final dose., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Under an environment that a vaccination rate is low and an infectious disease is prevalent, it is thought that most vaccinee got additional immunity by natural infection. On the other hand, in the area where the incidence of disease has been reduced by high rate vaccination, it is also decreased the chance of additional immunity by natural infection. Therefore susceptible individuals are increased because of the waning immunity. In the community where a vaccination rate is high, it may be necessary to consider the booster vaccination for adolescent and adult even if one completed the primary vaccinations. It may also be important to explore the timing of booster dose. In this paper, we attempt to give a comprehensive explanation of mathematical model for predicting the antibody duration, and we introduce the role of mathematical model on a consideration to the need and timing of booster doses after the primary series.

Measles and rubella combined (MR) vaccine and two-dose-vaccination have been used in Japan since 2006. only children undergoing monovalent measles and rubella vaccination undergo a second vaccination. We intend to administer MR vaccine twice to Japanese children from 2011, so studied the safety and efficacy of two-dose MR vaccination. Subjects were 75 pre school children undergoing MR vaccine manufactured by Biken at one year old in a clinical trial. Children were observed for adverse events for 28 days after the second MR vaccination. Efficacy was determined by measuring antibodies for measles and rubella before and after (six to eight weeks later) the second vaccination. Results showed that fever frequency decreased significantly from 27.3% to 14.9% (p < 0.05), and eruption decreased from 12.2% to 6.8% from the first to the second vaccination, whereas, the frequency of redness and swelling at the inoculation site increased from 7.3% to 10.8% and 2.9% to 8.1%. Differences are not statistically significant. Measles antibody titer determined by NT assay and rubella antibody titer measured by HI assay increased significantly from prevaccination to postvaccination (p < 0.0001). Measles antibodies measured by NT and EIA assays and rubella antibody measured by HI assay turned positive in all subjects after the second MR vaccination. In conclusion, two-dose MR vaccination should be safe and effective in eliminating measles and rubella in Japan.

In Japan, mass vaccination for diphtheria, pertussis, and/or tetanus has been mandated by the Vaccination Law since 1948. In order to evaluate the efficacy of this vaccination policy, we conducted seroepidemiological studies on pertussis, diphtheria, and tetanus among individuals aged 0 - 80 years. The pertussis toxin seropositive rates of the vaccine-eligible groups and vaccine-ineligible groups were 55.0 and 57.9%, respectively. The seropositive rate of each group for diphtheria antitoxin was 76.3 and 75.7%, respectively. The tetanus antitoxin seropositive rates were 91.7 and 10.5%, respectively, showing a significant difference between the two groups (P < 0.001). For the three diseases, variations were seen between age groups in the geometric mean antibody titers due to changes of the vaccination program. The results of this study show that natural Bordetella pertussis infection has occurred more frequently than expected. In order to establish the most appropriate vaccination program for the control of pertussis, diphtheria, and tetanus in Japan, further evaluation is necessary.

Background Japanese encephalitis (JE) is the leading cause of viral encephalitis with high mortality and morbidity in Asia. In Japan, however, the active recommendation of JE vaccine was retracted in 2005 because of the potential risk of acute disseminated encephalomyelitis. We aimed to determine the recent incidence of childhood-onset JE after the domestic change of vaccination policy in Japan, and to analyze the clinical features of affected children. Methods A retrospective nationwide survey was conducted for pediatric patients with JE in Japan from 1995 to 2015. The national surveillance system was used to identify the pediatric patients with JE. Follow-up questionnaires were sent to analyze their clinical and neuroimaging profiles. Results Among a total of 109 patients registered to the national surveillance, 10 (9%) were less than age 15 years. The annual incidence rate of childhood-onset JE was higher during 2005–15 than that during 1995–2004 (4.3 × 10–3 vs 1.1 × 10–3 per 100000, respectively; P =.04). Endemic regions overlapped with prefectures that farmed pigs harboring antibodies against JE virus with high prevalence. Detailed clinical data were collected from 9 patients. None of them died, but 5 of 9 patients (56%) had neurological sequelae after recovery. One patient who was partially vaccinated with 2 doses of JE vaccine fully recovered from a coma. The age of 3 years or less was associated with unfavorable neurological prognosis. Conclusions Our data provide evidence for the importance and prophylactic effect of the JE vaccine in young children in the endemic area. [ABSTRACT FROM AUTHOR]

Thirty-one Japanese nonresponders to subcutaneous hepatitis B vaccination and 15 medical personnel who were accidentally exposed to specimens positive for hepatitis B e antigen and were given hepatitis B immunoglobulin were intradermally immunized with 5 micrograms of plasma-derived hepatitis B vaccine every 2 weeks until delayed type hypersensitivity skin reaction to hepatitis B surface antigen became positive. Thirty (97%) of the 31 nonresponders developed delayed type hypersensitivity skin reactions to hepatitis B surface antigen after 2.3 +/- 1.2 (mean +/- SD) revaccinations. Twenty-nine (94%) of the 31 nonresponders had anti-hepatitis B surface antigen antibody levels greater than 10 IU/L. The immunoglobulin subclass of the antibody to hepatitis B surface antigen was mainly IgG1. After 1 year, 23 (74%) of the 31 nonresponders continued to have anti-hepatitis B surface antigen antibody levels greater than 10 IU/L. Persons accidentally exposed to specimens positive for hepatitis B e antigen developed delayed type hypersensitivity skin reactions to hepatitis B surface antigen following 3.1 +/- 1.1 revaccinations. None developed clinical hepatitis. There was no production of anti-hepatitis B core antigen antibody 1 year after exposure, indicating that protection was 100%. Intradermal hepatitis B vaccination is useful in reversing nonresponsiveness to hepatitis B surface antigen and for prophylaxis after exposure. [ABSTRACT FROM AUTHOR]

• In Japan, Prenatal DTaP vaccination lacks required safety information. • Pertussis seroprevalence is approximately 70% among pregnant Japanese women. • Maternal antibody titers in early pregnancy reflect infant antibody titers. • Preconception DTaP vaccination is one way to obtain maternal immunity. • A national survey to evaluate the safety information of prenatal DTaP is necessary. An increasing number of countries have been introducing acellular pertussis vaccination during pregnancy for the prevention of neonatal pertussis. In response to the fact that infantile pertussis cases of 0–5 months age groups remained unchanged despite the universal vaccination program, prenatal pertussis vaccination has been a rising issue in Japan. Hence, we investigated the seroprevalence of pertussis, diphtheria, and tetanus antibodies in Japanese pregnant women and neonates, and evaluated the necessity of diphtheria-tetanus-acellular pertussis (DTaP) vaccination during the preconception or prenatal period. Maternal PT-IgG (EIA) and FHA-IgG (EIA) for the first trimester, within 1 week after delivery, and cord blood were collected, along with colostrum pertussis-IgA (ELISA), diphtheria-IgG (EIA), tetanus-IgG (EIA), and blood samples from the first trimester. The maternal seroprevalence of PT-IgG and FHA-IgG was 69 % and 75 %, respectively. All tested participants were positive for diphtheria-IgG and tetanus-IgG (100 %). First trimester PT-IgG/FHA-IgG antibody titers were significantly associated with cord blood PT-IgG/FHA-IgG titers (P < 0.001). We found that pertussis seroprevalence among pregnant Japanese women was approximately 70 %. The antibody seropositivity rate of pertussis was lower than that of diphtheria and tetanus. Fetal acquired passive immunity against pertussis is higher when the level of maternal antibody in the first trimester is sufficient. At least 30 % of study population did not reach to the threshold value to provide sufficient pertussis immunity for the neonates and themselves. The acellular pertussis vaccine (DTaP) approved in Japan lacks safety information for pregnancy, hence, a solution for prompt administration of prenatal acellular pertussis vaccination might be introducing DTaP in the preconception period. [ABSTRACT FROM AUTHOR]

Abstract: Vaccinations for children with allergic diseases often need to be postponed or terminated because of the presumed risk of an immediate-type allergic reaction such as anaphylaxis. A new skin test protocol for predicting allergic reactions using the vaccine itself and the following stepwise vaccination method were developed and tested. Intradermal tests using 1:10 and 1:100 diluted measles vaccine indicated that the former was superior to the latter because a positive reaction against 1:10 diluted vaccine was found in 28.6% of 49 patients with severe allergic diseases including bronchial asthma, atopic dermatitis, food allergies and allergies to two or more allergens with high levels of IgE, as compared with the reaction against 1:100 diluted vaccine in 10.2% of the patients. Patients negative for 1:10 skin tests were safe from the following full-dose vaccine shots. Three patients showed very strong local reactions against measles vaccine, and avoided receiving the following full-dose shot. Positive reactions to skin tests of 1:10 diluted vaccine were found in 11 patients, who were given stepwise vaccinations. Three patients had adverse reactions, and two of them had been negative for 1:100 skin tests. In the case of influenza vaccine, skin tests were again more sensitive to 1:10 than to 1:100 diluted vaccine, because 3 out of 14 patients with positive reactions showed immediate-type adverse reactions against the following stepwise vaccinations, and 1 of them was negative for the 1:100 skin test. Moreover, the results of the skin prick test (undiluted vaccine) and the intradermal skin test (1:10 diluted vaccine) indicated that the latter was more useful in both cases of measles (54 patients) and influenza vaccine (69 patients). Overall, the skin test using 1:10 diluted vaccine was the more suitable for predicting an immediate-type reaction to measles and influenza vaccinations. Patients having negative 1:10 skin tests can be expected to show no adverse reactions to the remaining injections and even the positive subjects will complete the course of vaccine doses by the stepwise method. [Copyright &y& Elsevier]

Highlights • An active surveillance through a phased introduction of the Hib vaccine in Japan was studied. • Hib disease incidence decreased significantly after vaccine introduction. • Hif and non-typeable H. influenzae were isolated from a few cases. • Serotype replacement was not observed after the introduction of the Hib vaccine. • Continuous capsular typing and strain identification surveillance is important. Abstract Background Haemophilus influenzae type b (Hib) vaccine was introduced as a voluntary vaccine in December 2008 and was included in the national routine immunization program in April 2013 in Japan. Currently, no nationwide data are available to evaluate the effectiveness of Hib vaccine in Japan. Methods To evaluate the effectiveness of Hib vaccine in Japan, nationwide active population-based surveillance of culture-proven invasive infections caused by H. influenzae in children was performed in 2008–2017 in 10 prefectures in Japan (covering approximately 23% of the total Japanese population). Clinical data were recorded on a standardized case report form. Capsular type and antimicrobial susceptibility of the H. influenzae isolates were examined. The incidence rate ratio (IRR) and its confidence interval (CI) were calculated to compare data from 5 years before and that from after the introduction of the national routine Hib vaccine immunization program. Results During the 10-year study period, 566 invasive H. influenzae disease cases including 336 meningitis cases were identified. The average number of invasive H. influenzae disease cases among children <5 years of age during 2013–2017 decreased by 93% (IRR: 0.07, 95%CI 0.05–0.10, p < 0.001) compared with those occurring during 2008–2012. Hib strains have not been isolated from invasive H. influenzae disease cases since 2014; however, non-typeable H. influenzae and H. influenzae type f isolates have been noted as causes of invasive H. influenzae diseases among children <5 years in the post-Hib vaccine era. Conclusions After the governmental subsidization of the Hib vaccine, invasive Hib disease cases decreased dramatically in the study population, as per our surveillance. Continuous surveillance is necessary to monitor the effectiveness of Hib vaccine and for detecting any emerging invasive capsular types. [ABSTRACT FROM AUTHOR]