Study of the immunogenicity and infectivity of hepatitis B-containing stabilized plasma-protein solution.

In early 1984, five patients who were undergoing plasmapheresis at a Melbourne hospital developed a transient hepatitis B surface antigenaemia. A common batch of stabilized plasma-protein solution (SPPS) that was included in the replacement therapy for each patient was found to contain hepatitis B surface antigen (HBsAg). A follow-up study was undertaken of these patients and others who were known to have received SPPS from the same batch (in total, 10 patients were followed for a median of 46.5 weeks). No patient developed evidence of hepatitis, although one patient developed antibody to surface antigen. It was concluded that the manufacturing process was effective in destroying the infectivity of the HBsAg-positive plasma that was used in this batch of SPPS and that the final product was poorly immunogenic in these patients.