A Pre-Clinical Safety Evaluation of SBP (HBsAg-Binding Protein) Adjuvant for Hepatitis B Vaccine

PLoS One. 2017 Jan 19;12(1):e0170313. doi: 10.1371/journal.pone.0170313. eCollection 2017.

Abstract

Although adjuvants are a common component of many vaccines, there are few adjuvants licensed for use in humans due to concerns about their toxic effects. There is a need to develop new and safe adjuvants, because some existing vaccines have low immunogenicity among certain patient groups. In this study, SBP, a hepatitis B surface antigen binding protein that was discovered through screening a human liver cDNA expression library, was introduced into hepatitis B vaccine. A good laboratory practice, non-clinical safety evaluation was performed to identify the side effects of both SBP and SBP-adjuvanted hepatitis B vaccine. The results indicate that SBP could enhance the HBsAg-specific immune response, thus increasing the protection provided by the hepatitis B vaccine. The safety data obtained here warrant further investigation of SBP as a vaccine adjuvant.

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adjuvants, Immunologic / toxicity
  • Animals
  • Carrier Proteins / administration & dosage*
  • Carrier Proteins / immunology
  • Carrier Proteins / toxicity
  • Drug Evaluation, Preclinical
  • Female
  • Guinea Pigs
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B Surface Antigens / metabolism*
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / immunology
  • Hepatitis B Vaccines / toxicity
  • Humans
  • Macaca fascicularis
  • Male
  • Mice
  • Mice, Inbred ICR
  • Rats
  • Rats, Sprague-Dawley

Substances

  • Adjuvants, Immunologic
  • Carrier Proteins
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines

Grants and funding

This work was supported by the National Major Scientific and Technological Special Project (2012ZX10002006-002-003, http://www.nmp.gov.cn/zxjs/zdxy/201012/t20101208_2128.htm), the National High Technology Research and Development Program of China (2011AA02A114, http://program.most.gov.cn/), the National Natural Science Foundation of China (31370927 and 30571650, http://www.nsfc.gov.cn/) and the Science and Technology Innovation Action Plan of Shanghai (13431900602, http://www.dragon-star.eu/call/shanghai-2013-st-innovation-action-plan-international-cooperation-programme/).