Safety and immunogenicity of gelatin-free varicella vaccine in epidemiological and serological studies in Japan

• Published in: Vaccine Vol. 23; no. 10; pp. 1205 - 1208
• Main Authors: Ozaki, Takao, Nishimura, Naoko, Muto, Taichiro, Sugata, Ken, Kawabe, Shinji, Goto, Kensei, Koyama, Kuniaki, Fujita, Hiroyuki, Takahashi, Yoshiyuki, Akiyama, Masataka
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 26.01.2005; Elsevier; Elsevier Limited
• Subjects: Allergies; Anaphylaxis; Anaphylaxis - epidemiology; Antibodies, Viral - analysis; Antibodies, Viral - biosynthesis; Applied microbiology; Biological and medical sciences; Chicken pox; Chickenpox Vaccine - adverse effects; Chickenpox Vaccine - immunology; Child; Child, Preschool; Children & youth; Enzyme-Linked Immunosorbent Assay; Excipients; Female; Fundamental and applied biological sciences. Psychology; Gelatin; Human viral diseases; Humans; Hypersensitivity - epidemiology; Immunization; Immunoglobulin E - analysis; Immunoglobulin E - biosynthesis; Infant; Infectious diseases; Japan - epidemiology; Male; Medical sciences; Microbiology; Product Surveillance, Postmarketing; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Varicella vaccine; Varicella-zoster virus; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; Asia; Japan; Varicella vaccine; Gelatin; Anaphylaxis; Infection; Immunopathology; Allergy; Skin disease; Immunogenicity; Toxicity; Viral disease; Varicella; Vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2004.08.040

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.