Safety and immunogenicity of hepatitis B vaccine ButaNG in adults

Abstract

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 &mgr;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 &mgr;g was more effective than in 10 &mgr;g. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.

Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

“…The vaccine contains (in 1 ml) 20 µg of HBsAg, aluminium hydroxide up to 1.25 mg (in Aluminium), and thimerosal 0.05 mg. In pre-licensure studies Butang showed low reactogenicity and good immunogenicity in adults (Costa et al 1997, Ioshimoto et al 1999, but additional studies were considered necessary. We report the results of a study conducted to assess the performance of the Butantan hepatitis B vaccine, compared to Engerix B®, which is produced using as expression system S. cerevisiae and widely used and acknowledged as safe and immunogenic both in Brazil and abroad.…”

“…The vaccine contains (in 1 ml) 20 µg of HBsAg, aluminium hydroxide up to 1.25 mg (in Aluminium), and thimerosal 0.05 mg. In pre-licensure studies Butang showed low reactogenicity and good immunogenicity in adults (Costa et al 1997, Ioshimoto et al 1999, but additional studies were considered necessary. From 1997From to 2003,465 doses of hepatitis B vaccine have been purchased by the Ministry of Health, 54% of which imported and 46% produced domestically.…”

Brazilian hepatitis B vaccine: a six-year follow-up in adolescents

“…These vaccines are highly immunogenic and safe and induce protection against hepatitis B infections for at least 20 years , Poorolajal et al 2010). Today, highly immunogenic hepatitis B vaccines comprising recombinant HBsAg generated using different yeast expression systems are available, but there are no data on anti-HBs persistence (Ioshimoto et al 1999, Hieu et al 2002, Vijayakumar et al 2004, Zhang et al 2011.…”

“…This vaccine is produced by Butantan Institute and the recombinant antigen is expressed using the Hansenula polymorpha yeast cell expression system (Ioshimoto et al 1999). This system is less expensive and more productive than S. cerevisiae expression systems, thereby reducing the price of individual vaccine doses (Hieu et al 2002).…”

Presence of maternal anti-HBs antibodies does not influence hepatitis B vaccine response in Brazilian neonates

“…The Brazilian recombinant HBV vaccine (Butang ® ) is produced by Butantan Institute (IB) with genetic engineering technology that uses Hansenulla polymorpha yeast cells (Ioshimoto et al 1999). The advantage of this yeast expression system when compared to other expression systems (such as Saccharomyces cerevisiae) is that its expression is 4-10 times higher, reducing the production costs (Hieu et al 2002).…”