Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine

André, Francis

doi:10.1016/0002-9343(89)90525-1

Cited by 185 publications

(80 citation statements)

References 18 publications

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“…A comparison between different studies on the immunogenicity of hepatitis B vaccines is difficult, due to differences in vaccine characteristics and formulation, vaccination schedules, vaccination sites, injection procedures, timing of blood sampling, sensitivity of laboratory methods, and unexplained factors, resulting in a wide range of seroprotection and anti-HBs geometric mean titers (GMTs) with the same vaccine (André 1989, Greenberg 1993, Adkins & Wagstaff 1998, Mahoney & Kane 1999, Assad 1999, Keating & Noble 2003.…”

Section: Discussionmentioning

confidence: 99%

“…Based on previous studies with Engerix B® at the National Reference Laboratory on Viral Hepatitis at Fiocruz in Rio de Janeiro (NRLVH) in full-term newborns (Motta et al 2002) and on other studies in children and adolescents (Ferreira et al 1993, André 1989, Greenberg 1993, Adkins & Wagstaff 1998, Mahoney & Kane 1999, Assad 1999, we anticipated 98% of seroprotection (SP), that is, antibody titer ≥ 10 milli International Units per millilitre (mIU/ml). Based on a more conservative estimate -95% -we found that 258 subjects would be necessary for 80% power to show equivalence defined as difference in seroconversion rates not larger than 5 percentage points between the two vaccines.…”

Section: Methodsmentioning

confidence: 99%

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

Felzemburgh

Bensabath

Arraes

et al. 2004

Mem. Inst. Oswaldo Cruz

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The immunogenicity and safety of a new recombinant hepatitis B vaccine from theButang® hepatitis B vaccine has been developed and is produced by Instituto Butantan (IB), with genetic engineering technology, using Hansenulla polymorpha yeast cells. The advantage of this yeast expression system as compared to other expression systems (such as Saccharomyces cerevisiae) is that expression is estimated to be 4 to 10 times higher, helping to decrease the production costs (Hieu et al. 2002). 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. Development and production of hepatitis B vaccine by IB is part of a project to strengthen the Brazilian vaccine industry, a policy that has been pursued by the Brazilian NIP as a means to decrease vulnerability to market uncertainties. In the past, immunization activities have been jeopardized by insufficient availability of vaccines from international manufacturers. The capacity to both produce a vaccine and demonstrate its satisfactory performance with high scientific standards is strategic for developing countries. MATERIALS AND METHODSStudy design -This was a double-blind, prospective equivalence study in three centers in Brazil to assess and compare the immunogenicity of a Brazilian hepatitis B recombinant vaccine (Butang®, 20 µg/ml), to a commercially available vaccine as an active control (Engerix B®, 20 µg/ ml). Three centers in different regions of the country followed the same research protocol and addressed differ-

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

Felzemburgh

Bensabath

Arraes

et al. 2004

Mem. Inst. Oswaldo Cruz

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“…[19][20][21][22][23][24][25][26][27] Studies suggest that higher HBsAg formulation of HBV vaccines may be associated with faster seroconversion rates and higher peak antibody levels, as well as improved sero-protection rates in populations difficult to immunize. [28][29][30] Since 2012, Chinese authorities abolished 5 mg HBV vaccines and defined 10 mg HBV vaccines for use in neonates, infants, and children up to and including 15 years of age.…”

Section: Immunization Strategies For Children and High Risk Populatiomentioning

confidence: 99%

Strategy vaccination against Hepatitis B in China

Liao

Liang²

2015

Human Vaccines & Immunotherapeutics

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Hepatitis B (HB) is a serious public health problem in China. Up to now, the hepatitis B virus (HBV) vaccination was the most cost-effective way to prevent HBV infection. Since 1992, when the Chinese government prioritized implementing the HBV vaccinations for newborns, China began to see a larger reduction in HBV infections. For children under 5 years, the prevalence of hepatitis B surface antigen (HBsAg) has decreased to 1.0%. However, many additional challenges for the prevention and control of HBV infection in China remain. There is a lack of knowledge of the significant impact of the HBV vaccination for the general public with 93 million HBV carriers and chronic HBV patients as infection sources. Therefore, the HBV vaccine application should focus on the optimization of immunization strategies according to HBV prevalence characteristics, improve the public's knowledge of HBV vaccinations, and help to ensure the protective effects of the HBV vaccine.

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“…1 Currently available hepatitis B vaccines comprise recombinant hepatitis B surface antigen (HBsAg) expressed in yeast cells adsorbed to an alum adjuvant. 2 After the recommended threedose regimen with a minimum interval of one month between the first two doses and at least four months between the second and third doses, 2-4 a substantial proportion (5-10%) of healthy young adults fail to achieve a protective immune response (defined as an anti-HBs concentration ≥ 10 mIU/mL). [5][6][7] Risk factors associated with increased rates of nonresponse include obesity, smoking, increased age, immunodeficiency, and genetic factors.…”

Section: Introductionmentioning

confidence: 99%