title: Safety and immunogenicity of gelatin-free varicella vaccine in epidemiological and serological studies in Japan.
abstract: Following gelatin-containing varicella vaccine (1994-1999: 1,410,000 distributed doses), 28 serious anaphylactic reactions and 139 non-serious allergic reactions were reported, with no serious and only five non-serious reactions following gelatin-free vaccine (1999-2000: 1,300,000 distributed doses). All nine sera available from children with serious reactions tested positive for gelatin-specific IgE, whereas 55 of the 70 available from those with non-serious reactions were positive, with one false positive. There was no correlation between gelatin-specific IgE antibody titers and severity of allergic reaction. Post-immunization anti-varicella antibody titers were comparable for both gelatin-free and gelatin-containing vaccine groups. The new gelatin-free varicella vaccine is thought to be safe, with similar immunogenicity to the earlier gelatin-containing vaccine.
authors.affiliation: Department of Pediatrics, Showa Hospital, Konan, Aichi 483-8703, Japan. sh-t-oz@showa.jaaikosei.or.jp
authors.forename: Takao
authors.initials: T
authors.lastname: Ozaki
authors.forename: Naoko
authors.initials: N
authors.lastname: Nishimura
authors.forename: Taichiro
authors.initials: T
authors.lastname: Muto
authors.forename: Ken
authors.initials: K
authors.lastname: Sugata
authors.forename: Shinji
authors.initials: S
authors.lastname: Kawabe
authors.forename: Kensei
authors.initials: K
authors.lastname: Goto
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Koyama
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujita
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Masataka
authors.initials: M
authors.lastname: Akiyama
mesh_terms: D000707:Anaphylaxis / Q000453:epidemiology; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D019433:Chickenpox Vaccine / Q000009:adverse effects* / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005079:Excipients; D005260:Female; D005780:Gelatin; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology; D007073:Immunoglobulin E / Q000032:analysis / Q000096:biosynthesis; D007223:Infant; D007564:Japan / Q000453:epidemiology; D008297:Male; D011358:Product Surveillance, Postmarketing; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D005079:Excipients; D014613:Vaccines, Attenuated; D007073:Immunoglobulin E; D005780:Gelatin