Virus inactivation by addition of neutralizing antibodies.

This study has shown that the principle of virus neutralization by specific antibodies is feasible at least in the case of hepatitis B. Virus neutralization is our preferred method since it entails no loss of functional activity and no risk of induction of neo-antigens in the plasma derivatives. Although double-blind clinical trials have not been performed, this study--in combination with some other studies - brought the conclusive evidence that virus neutralization in the case of hepatitis B transmission is efficacious.

Contributions to the optimal use of human blood. IX. Elimination of hepatitis B transmission by (potentially) infectious plasma derivatives.

Investigations were performed concerning the elimination of the risk of hepatitis B transmission of potentially infectious plasma derivatives by the addition of a low dose of hepatitis B immunoglobulin (HBIg). To this end, clotting factor VIII concentrate, prothrombin complex, C1 esterase inhibitor concentrate, plasminogen and antithrombin III were prepared from plasma strongly positive for hepatitis B surface antigen (HBsAg). To one half of every preparation, HBIg was added up to a final concentration of 0.

Immunogenicity and safety of heat-inactivated hepatitis B vaccine (CLB) in low risk human volunteers and in patients treated with chronic haemodialysis in the Netherlands.

The immunogenicity and safety of a heat-inactivated hepatitis B vaccine (HB-vaccine) were studied in healthy human volunteers (n = 471) at a low risk to be infected with hepatitis B virus (HBV) and in patients on chronic haemodialysis (n = 227), who were treated in hepatitis B free centres. After vaccination with 3 injections of 3 micrograms heat-inactivated HBsAg adsorbed to A1PO4, given at monthly intervals, 93% of the healthy low risk volunteers had formed anti-HBs. The haemodialysis patients were randomly divided into 2 groups, which were vaccinated with 3 monthly injections of 3 micrograms and 27 micrograms heat-inactivated HBsAg, respectively.

Prothrombin complex concentrates for clinical use.

Prothrombin complex concentrates prepared for clinical use are reviewed with emphasis on frequently observed adverse reactions such as viral hepatitis and thromboembolic complications. Preparation procedures and quality control are described briefly, and the use of these concentrates in the treatment of hemophilia A patients who develop factor VIII inhibitors is also described. The causes of and methods for the detection of potential thrombogenicity are discussed and suggestions which may result in a safer product are made.