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

• Published in: PloS one Vol. 12; no. 1; p. e0170313
• Main Authors: Wang, Jingbo, Su, Caixia, Liu, Rui, Liu, Baoxiu, Khan, Inam Ullah, Xie, Jun, Zhu, Naishuo
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 01.01.2017; Public Library of Science (PLoS)
• Subjects: Adjuvants; Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - toxicity; Aluminum; Animals; Antigens; Binding; Biology and Life Sciences; Carrier Proteins - administration & dosage; Carrier Proteins - immunology; Carrier Proteins - toxicity; Dosage and administration; Drug dosages; Drug Evaluation, Preclinical; Evaluation; FDA approval; Female; Genetic engineering; Guinea Pigs; Health aspects; Hepatitis; Hepatitis B; Hepatitis B Antibodies - biosynthesis; Hepatitis B surface antigen; Hepatitis B Surface Antigens - immunology; Hepatitis B Surface Antigens - metabolism; Hepatitis B vaccines; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - immunology; Hepatitis B Vaccines - toxicity; Humans; Immune response; Immune system; Immunogenicity; Immunology; Laboratory animals; Life sciences; Liver; Lung cancer; Macaca fascicularis; Male; Medical research; Medicine and Health Sciences; Mice; Mice, Inbred ICR; Physiological aspects; Protein binding; Proteins; Rats; Rats, Sprague-Dawley; Research and Analysis Methods; Safety; Side effects; Studies; Toxicity; Toxicology; Vaccines
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0170313

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.