Safety and immunogenicity of gelatin-free varicella vaccine in epidemiological and serological studies in Japan.
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.
Ozaki
Takao
T
Department of Pediatrics, Showa Hospital, Konan, Aichi 483-8703, Japan. sh-t-oz@showa.jaaikosei.or.jp
Nishimura
Naoko
N
Muto
Taichiro
T
Sugata
Ken
K
Kawabe
Shinji
S
Goto
Kensei
K
Koyama
Kuniaki
K
Fujita
Hiroyuki
H
Takahashi
Yoshiyuki
Y
Akiyama
Masataka
M
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
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D005079:Excipients; D014613:Vaccines, Attenuated; D007073:Immunoglobulin E; D005780:Gelatin