Clinical trials of hepatitis B immune globulin. Development of policies and materials for the 1972-1975 studies sponsored by the National Heart and Lung Institute.
Plasma from persons with high titers of hepatitis B antibody (anti-HBs) was used to manufacture one lot of hepatitis B "immune" globulin sufficient for four interlocking clinical trials of prevention or modification of hepatitis B infections. The trials were carried out in renal dialysis units, in medical personnel with accidental exposures to hepatitis B, in transfused patients, and in patients with fulminant hepatitis. A single policy board developed protocols that allowed comparisons among the four studies while respecting the unique requirements of each.
D000906:Antibodies; D002353:Carrier State / Q000453:epidemiology; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000008:administration & dosage / Q000032:analysis; D006511:Hepatitis B Antigens / Q000032:analysis; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage / Q000627:therapeutic use*; D009316:National Institutes of Health (U.S.); D012107:Research Design; D013997:Time Factors; D014481:United States
D000906:Antibodies; D006510:Hepatitis B Antibodies; D006511:Hepatitis B Antigens; D007136:Immunoglobulins