L. A. Smallwood

Center for Biologics Evaluation and Research

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Robert J. Gerety

Biogen (United States)

Edward Tabor

George Washington University

Lewellys F. Barker

Aeras

R. J. Gerety

Center for Biologics Evaluation and Research

Friedrich Deinhardt

Presbyterian St. Luke's Medical Center

Richard E. Sampliner

University of Arizona

J Drucker

Institut de Veille Sanitaire

J.S. Finlayson

Center for Biologics Evaluation and Research

Eugene B. Buynak

United States Military Academy

L. F. Barker

Binus University

Cooperative Institutions

Center for Biologics Evaluation and Research

National Institutes of Health

United States Food and Drug Administration

American Red Cross

National Institute of Allergy and Infectious Diseases

Institute of Medical Microbiology and Hygiene

National Institute of Diabetes and Digestive and Kidney Diseases

Merck & Co., Inc., Rahway, NJ, USA (United States)

United States Military Academy

University of Pennsylvania

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Antibodies to Hepatitis A Virus in Immune Serum Globulin

Journal of Medical Virology (1981)

L. A. Smallwood Edward Tabor J.S. Finlayson R. J. Gerety

Abstract Two hundred one immune serum globulin (ISG) lots manufactured in the US between 1967 and 1977 were tested for antibodies to the hepatitis A virus (anti‐HAV) by a competitive‐inhibition radioimmunoassay (RIA); a lesser number were also tested by immune adherence hemagglutination (IAHA). The percentage of ISG lots that contained anti‐HAV with a titer of 1:100 or greater by RIA was 50% for those manufactured in 1967, 69% for those manufactured in 1972, and 100% for those manufactured in 1977. The percentage of lots with anti‐HAV titers equal to or greater than 1:500 by RIA was 7% in 1967, 18% in 1972, and 70% in 1977. Only ten lots of ISG (5%) had anti‐HAV titers of 1:1,000 or greater by RIA; seven of these were manufactured in 1977. Both the mean titer of anti‐HAV in ISG lots and the percentage of lots containing significant titers of this antibody appear to have increased in the US over the past ten years. This may reflect the increased use of source plasma from paid plasmapheresis donors in the US during this period. The lower titers of anti‐HAV in the older lots of ISG studied were shown not to be due to fragmentation of antibody molecules during storage.

Hemagglutination assay

10.1002/jmv.1890070103

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Citations (10)

Serologic Markers of Hepatitis A and B in the Population of Bali, Indonesia

American Journal of Tropical Medicine and Hygiene (1985)

Paul Brown R. M. Moerdowo Georges Bréguet R Ney Robert J. Gerety

A total of 343 sera from Balinese subjects in different age groups and geographic locations were tested by radioimmunoassay (RIA) for serum antibodies to hepatitis B surface antigen (anti-HBs) and hepatitis B core antigen (anti-HBc); most sera were also tested for hepatitis B surface antigen (HBsAg), and for antibody to hepatitis A virus (anti-HAV). One hundred percent of the adult population was found to have anti-HAV, with antibody acquisition beginning in early childhood and reaching a level of 95% by the age of 10 years. Antibodies to hepatitis B virus were also frequent in young children, rapidly peaking to near 80% in older children and adolescents, then declining to a plateau that fluctuated between 40% and 60% throughout adult life. Overall, anti-HBc (49%) was detected slightly more often than anti-HBs (45%), but the relative frequencies of the 2 antibodies varied considerably from group to group. Despite these high antibody prevalences, HBsAg was detected in only 1.5% of the general population, and in no woman of child-bearing age. In utero infection is thus far less likely to account for the early acquisition of antibody to hepatitis B virus than inapparent percutaneous transmission occurring under conditions of close personal contact.

Hepatitis B

10.4269/ajtmh.1985.34.616

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Citations (15)

Subtyping of Hepatitis B Surface Antigen and Antibody by Radioimmunoassay

Gastroenterology (1977)

Jay H. Hoofnagle Robert J. Gerety L. A. Smallwood Lewellys F. Barker

Subtyping

Hepatitis B

Counterimmunoelectrophoresis

10.1016/s0016-5085(77)80089-9

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Citations (87)

Inactivation of hepatitis B virus by three methods: Treatment with pepsin, urea, or formalin

Journal of Medical Virology (1983)

Edward Tabor Eugene B. Buynak L. A. Smallwood Philip Snoy M. R. Hilleman

Abstract Dilutions of human sera containing between 10 3 and 10 5 chimpanzee infectious doses of hepatitis B virus per ml, subtype adr or ayw, were treated with either 1 m̈g/ml pepsin at pH 2.0 for 18 hours, 8 M urea for four hours, or 1:4,000 formalin for 72 hours. One ml of the serum containing hepatitis B virus subjected to each of the procedures was inoculated intravenously into one or two susceptible chimpanzees (total of eight chimpanzees). No evidence of hepatitis B infection was detected in weekly serum samples from the chimpanzees during six months of observation. These three procedures are currently applied during manufacture to inactivate HBV which might be present in the hepatitis B vaccine licensed in the United States. The data from this study combined with data documenting that the physical purification of the vaccine is capable of removing hepatitis B virus provide assurance that there is no residual live hepatitis B virus in the vaccine.

Pepsin

Serial dilution

Hepatitis B

Hepatitis B vaccine

10.1002/jmv.1890110102

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Citations (51)

Studies of Donors Who Transmit Posttransfusion Hepatitis

Transfusion (1979)

Edward Tabor J H Hoofnagle L. A. Smallwood J Drucker G. Pineda‐Tamondong

Sera and questionnaires were evaluated retrospectively from 128 volunteer blood donors whose blood had been implicated in cases of clinically recognized posttransfusion hepatitis in recipients of one‐ or two‐unit blood transfusions between 1971 and 1977. Serologic markers of hepatitis B virus (HBV) infection were found in 23 per cent, compared to 9.7 per cent of 3,230 prospective blood donors. The prevalence of antibody to hepatitis A virus was similar among implicated donors (44%), prospective donors (58%), and among those implicated donors with (41%) and without (44%) HBV markers. Among implicated donors, none had a history at the time of donation of having had clinically recognizable hepatitis, 93 per cent had no history of prior blood transfusion, and 80 per cent had normal hepatic enzymes. Data from this study confirm that non‐A, non‐B hepatitis has been a common form of posttransfusion hepatitis in recent years, since 77 per cent of these implicated donors had no HBV serologic markers. In addition, these donors could not be distinguished by age, race, sex, history of clinical hepatitis or of prior blood transfusion, or in most cases by hepatic enzyme levels.

Hepatitis B

Volunteer

10.1046/j.1537-2995.1979.19680104098.x

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Citations (67)

Community‐acquired non‐A, non‐B hepatitis: Clinical characteristics and chronicity

Journal of Medical Virology (1984)

Richard E. Sampliner Daniel Woronow Miriam J. Alter L. A. Smallwood Edward Tabor

Abstract The characteristics of 86 patients with acute non‐A, non‐B hepatitis were compared to 23 patients with acute hepatitis A and 76 with acute hepatitis B by medical record reviews of patients seen at 5 hospitals in Baltimore, Maryland, as part of case‐control study of viral hepatitis. Results of serum aminotransferase levels, bilirubin, albumin, and prothrombin times alone could not distinguish the type of viral hepatitis because of extensive overlap. The alanine aminotransferase range for non‐A, non‐B hepatitis was 56 to 1819 IU/liters, for hepatitis A 250 to 1995 IU/liters, and for hepatitis B 203 to 2120 IU/liters. The ranges of aspartate aminotransferase and bilirubin for the types of hepatitis also overlapped. Fewer patients with non‐A, non‐B hepatitis or hepatitis A had a prolonged prothrombin time compared to patients with hepatitis B. Hepatic encephalopathy was seen only in two patients with hepatitis B. Forty‐two percent of non‐A, non‐B hepatitis patients followed for 6 months or longer continued to have elevated alanine aminotransferase levels. Chronic alanine aminotransferase elevation was independent of the source of infection: transfusion, parenteral drug use, or all other sources. Prolonged follow‐up is necessary to evaluate chronicity in patients with non‐A, non‐B hepatitis.

Hepatitis B

Prothrombin time

Viral Hepatitis

Hepatic Encephalopathy

Hepatitis C

10.1002/jmv.1890130203

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Citations (23)

ANTIBODIES TO HEPATITIS A VIRUS IN IMMUNE SERUM GLOBULIN

The Lancet (1980)

L. A. Smallwood Edward Tabor J.S. Finlayson Robert J. Gerety

10.1016/s0140-6736(80)91921-2

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Citations (14)

Coincident Hepatitis B Surface Antigen and Antibodies of Different Subtypes in Human Serum

The Journal of Immunology (1977)

Edward Tabor Robert J. Gerety L. A. Smallwood Lewellys F. Barker

Summary Three patients with simultaneously detectable hepatitis B surface antigen (HBsAg) and antibody (anti-HBs) in their sera were studied for subtypes of HBsAg and anti-HBs. In each case anti-HBs was found to be directed to a different subtype than that of the circulating HBsAg, indicating that reinfection (or simultaneous infection) with a second subtype occurred.

Hepatitis B

10.4049/jimmunol.118.1.369

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Citations (72)

Serologic response in human hepatitis A: Detection of antibody by radioimmunoassay and immune adherence hemagglutination

Journal of Medical Virology (1979)

J Drucker L. A. Smallwood Douglas E. Lorenz Edward Tabor Pierre Coursaget

An indirect solid-phase radioimmunoassay (RIA) for detection of antibody to the hepatitis A antigen (anti-HAV) was developed using polystyrene pearls as the solid phase and hepatitis A antigen (HAAg) extracted from marmoset livers. This RIA was compared to an immune adherence hemagglutination assay (IAHA) which employed HAAg derived from the stools of chimpanzees collected during acute hepatitis A. Anti-HAV was detected in the sera of 15 humans with naturally acquired hepatitis A infection. Sensitivity and specificity were greater using the RIA, permitting the detection of anti-HAV as early as the time of onset of jaundice. Either seroconversion or a significant increase in the titer of anti-HAV was demonstrated following hepatitis A exposure in paired sera from six patients by both techniques. No significant difference in anti-HAV responses was noted between patients with icteric compared to anicteric hepatitis A or between children and adults with hepatitis A.

Seroconversion

Immune adherence

Hemagglutination assay

Hepatitis A vaccine

10.1002/jmv.1890040107

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Citations (11)

Summary of the Biosafety Workshop: Application of biosafety principles in blood establishments

Transfusion (1988)

F. Carl Grumet J. L. MacPherson Phillip Hoppe L. A. Smallwood

In light of increasing public and employee concern over potential infectious hazards associated with blood and other body fluids, several government agencies (the Food and Drug Administration, the Centers for Disease Control, the Occupational Safety and Health Administration, the Environmental Protection Agency, the Health Care Financing Administration and the National Heart, Lung and Blood Institute) cosponsored a Biosafety Workshop in April 1988. The objective of the workshop was to identify appropriate biosafety practices and standard control procedures to protect workers involved in the collection, storage, and transportation of human blood donations with the least possible disruption of the nation's blood supply. Speakers focused on human immunodeficiency virus (HIV) and hepatitis B virus (HBV); however, the safety principles discussed were considered equally applicable to other known (e.g., non-A, non-B hepatitis and human T-lymphotropic virus type I (HTLV-1) blood-transmitted infections. The resulting consensus included the need for blood establishments to develop and apply thoughtful biosafety programs to address staff training, accident prevention, HBV vaccination, handling spills, managing contaminated waste and transporting blood specimens. There was lack of agreement, however, on the usefulness of gloves during the phlebotomy of healthy blood donors.

Biosafety

Phlebotomy

Hepatitis B

10.1046/j.1537-2995.1988.28588337348.x

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Citations (7)