Newly Licensed Hepatitis B Vaccine
- 11 February 1983
- journal article
- research article
- Published by American Medical Association (AMA)
- Vol. 249 (6) , 745-746
- https://doi.org/10.1001/jama.1983.03330300029028
Abstract
THE RECENTLY licensed subunit hepatitis B vaccine (HEPATAVAX-B) is unique among vaccines in that it is manufactured solely from human plasma obtained from asymptomatic individuals with chronic hepatitis B. Plasma from donors selected for manufacturing this vaccine contains high concentrations of noninfectious hepatitis B surface antigen (HBsAg) particles and lower concentrations of infectious hepatitis B virus (HBV). The ratio of HBsAg to HBV can be as great as 10,000:1.1From the starting plasma, 22-nm spherical HBsAg particles are separated from HBV by ultracentrifugation. The 22-nm particles are then further purified by digestion with pepsin followed by the addition of 8M urea. Finally, the vaccine is treated with formaldehyde. Vaccine Plasma Donors Vaccine plasma donors are selected for their high titers of HBsAg. By federal regulation, they must be asymptomatic and in apparent good health.2They must meet all federal requirements for acceptable plasmapheresis donors, except that their serumKeywords
This publication has 1 reference indexed in Scilit:
- Inactivation of An Agent of Human Non-A, Non-B Hepatitis by FormalinThe Journal of Infectious Diseases, 1980