Safety and immunogenicity of hepatitis B vaccine ButaNG in adults

• Main Authors: Luzia M. IOSHIMOTO, Maria Lúcia RISSATO, Valentina S.J. BONILHA, Cosue MIYAKI, Isaias RAW, Nikolai GRANOVSKI
• Format: Article in Journal/Newspaper
• Language: English
• Published: Universidade de São Paulo (USP) 1999
• Subjects: Hepatitis B vaccine; Clinical trials; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doaj.org/article/10287d1c22004cd68e20cce398c315bc

Recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan was administered in two groups of adult volunteers (I, II) following two different schedules of immunization. In the first trial (10 m g doses and 0, 1, 3 months vaccination schedule) 106 individuals completed the full immunization program. The results of seroconversion by age group varied from 70 to 100% and the GMT from 46.5 to 124.9 mIU mL-1. In the second trial with 68 individuals (for dosage comparison and 0, 1, 6 months vaccination schedule) indicated that the vaccine formulated in 20 m g was more effective than in 10 m g. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.