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The article presents guidelines on working group for revision of guidelines for the use of Palivizumab in Japan. Topics include the precautions and indications on the drug's information leaflet, the appropriate use of this agent should be used on a patient by patient basis; and referring to guidelines issued by healthcare societies and other professional academic organizations.

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. [ABSTRACT FROM AUTHOR]

Background. Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP).Methods. A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations.Results. Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable.Conclusions. DTaP-sIPV was shown to be a safe and immunogenic vaccine.Clinical Trials Registration. JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp). [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]

Although anaphylaxis is an extremely rare vaccine-associated adverse event, it occurred in young children following administration of the 2011/12 seasonal split influenza vaccine, which contained 2-phenoxyethanol as the preservative. These children had high levels of IgE antibodies against influenza vaccine components. We herein investigated why these children were sensitized. One hundred and seventeen series of serum samples were obtained immediately before, and one month after the first and second immunizations with the HA split vaccine of 2011/12. Forty-two sequential serum samples were collected in the acute and convalescent phases (2 and 4 weeks) after natural infection with H1N1 Pdm in 2009. IgE antibodies developed following the vaccination of young children with seasonal split vaccines, whereas no significant IgE response was observed following natural infection with H1N1 Pdm 2009. The prevalence of IgE antibodies was not influenced by outbreaks of H1N1 Pdm. Repeated immunization with the HA split vaccine induced IgE sensitization against the influenza vaccine irrespective of the H1N1, H3N2, or B influenza subtypes. The reasons why anaphylaxis only occurred in recipients of the influenza vaccine containing 2-phenoxyethanol are still being investigated, and the size distribution of antigen particles may have shifted to a slightly larger size. Since the fundamental reason was IgE sensitization, current split formulation for the seasonal influenza vaccine needs to be reconsidered to prevent the induction of IgE sensitization. [ABSTRACT FROM AUTHOR]

Members of the Japanese Society of Pediatric Pulmonology and the Japanese Society for Pediatric Infectious Diseases developed the Guidelines for the Management of Respiratory Infectious Diseases in Children with the objective of facilitating the appropriate diagnosis and treatment of childhood respiratory infections. To date, a first edition (2004) and a revised edition (2007) have been issued. Many problems complicate the diagnosis of the pathogens responsible for bronchopulmonary infections in children. The Guidelines were the first pediatric guidelines in the world to recommend treatment with antimicrobials suited to causative pathogens as identified from cultures of sputum and other clinical specimens collected from infection sites and satisfying assessment criteria. The major causative microorganisms for pneumonia in infants and children were revealed to be Streptococcus pneumoniae, Haemophilus influenzae and Mycoplasma pneumoniae. This manuscript describes the Guidelines for the Management of Respiratory Infectious Diseases in Children in Japan 2007, with a focus on pneumonia. [ABSTRACT FROM AUTHOR]