PMID: 9194109Jun 1, 1997Paper

Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in neonates

The Pediatric Infectious Disease Journal
B YerushalmiR Dagan

Abstract

Most of the licensed hepatitis B vaccines produced by recombinant DNA contain the S protein component of the hepatitis B virus surface antigen particle but lack two important components, Pre-S1 and Pre-S2. These components have recently been shown to play an important immunogenic role by enhancing the hepatitis B surface antibody (anti-HBs) titers, stimulating response and circumventing genetic nonresponsiveness. To assess safety, tolerability and immunogenicity in neonates of a novel recombinant HBV vaccine (Bio-Hep-B) containing the S, Pre-S1 and Pre-S2 components compared with a licensed recombinant vaccine (Engerix-B) containing the S component only. Healthy neonates were randomized to receive either Bio-Hep-B (2.5 micrograms/dose) or Engerix-B (10 micrograms/dose) at ages < 24 h, 1 month and 6 months. Blood was obtained at ages 0, 1, 7 and 12 months. Tolerability was assessed by diary cards filled by the parents for 5 successive days after immunization. Immunogenicity was assessed by determination of anti-HBs antibody. Of 205 neonates 153 were in the Bio-Hep-B group and 52 were in the Engerix-B group. Both vaccines were well-tolerated and all infants became seroprotected (anti-HBs > 10 mIU/ml). After the first dose a signi...Continue Reading

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Citations

Jan 8, 2004·Journal of Hepatology·Daniel Shouval
Feb 23, 2002·Vaccine·Márcia Soares Freitas da MottaCleonice Barbosa Sandoval de Souza
Jun 5, 2013·Human Vaccines & Immunotherapeutics·Nelson F EngFrancisco Diaz-Mitoma
Dec 20, 2014·Medical Microbiology and Immunology·Wolfram H Gerlich
Jan 6, 2015·Medical Microbiology and Immunology·Daniel ShouvalMichael Roggendorf
Feb 18, 2018·Biotechnology Journal·Xuanwei DingYuan Lu
May 20, 2015·Journal of Pediatric Gastroenterology and Nutrition·Merav Heshin-BekensteinAri Silbermintz
Dec 2, 1998·Sozial- Und Präventivmedizin·D Desgrandchamps, C A Siegrist
Oct 30, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Elena V EsaulenkoFrancisco Diaz-Mitoma
May 15, 2021·The Lancet Infectious Diseases·Florian van Bömmel, Thomas Berg

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