Type B hepatitis after needle-stick exposure: prevention with hepatitis B immune globulin. Final report of the Veterans Administration Cooperative Study.
Hepatitis B immune globulin (HBIG) and immune serum globulin (ISG) were examined in a randomized, double-blind trial to assess their relative efficacies in preventing type B hepatitis after needle-stick exposure to hepatitis B surface antigen (HBsAG)-positive donors. Clinical hepatitis developed in 1.4% of HBIG and in 5.9% of ISG recipients (P = 0.016), and seroconversion (anti-HBs) occurred in 5.6% and 20.7% of them respectively (P less than 0.001). Mild and transient side-effects were noted in 3.0% of ISG and in 3.2% of HBIG recipients. Available donor sera were examined for DNA polymerase (DNAP) and e antigen and antibody (HBeAg; anti-HBE). Both DNAP and HBeAg showed a highly statistically significant correlation with the infectivity of HBsAg-positive donors. Hepatitis B immune globulin remained significantly superior to ISG in preventing type B hepatitis even when the analysis was confined to these two high-risk subgroups. The efficacy of ISG in preventing type B hepatitis cannot be ascertained because a true placebo group was not included.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004259:DNA-Directed DNA Polymerase; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control / Q000635:transmission*; D006511:Hepatitis B Antigens; D006514:Hepatitis B Surface Antigens; D006801:Humans; D007106:Immune Sera; D007136:Immunoglobulins / Q000627:therapeutic use*; D007267:Injections / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009339:Needles / Q000009:adverse effects*; D006435:Renal Dialysis; D014481:United States; D014493:United States Department of Veterans Affairs
D006511:Hepatitis B Antigens; D006514:Hepatitis B Surface Antigens; D007106:Immune Sera; D007136:Immunoglobulins; D004259:DNA-Directed DNA Polymerase