Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
To evaluate whether hepatitis B immune globulin with a high level of antibody against the
 hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis
 B virus, the single most important route of hepatitis spread in the entire Third World.
BACKGROUND:

 A baseline study on the vertical transmission of hepatitis B virus in Taiwan revealed that 15
 percent of all pregnant women were persistent carriers of hepatitis B antigen and that 40
 percent of their new babies developed a protracted antigenemia during the first 6 months of
 life. The incidence of acute hepatitis, cirrhosis, and hepatoma was high in Taiwan, and
 patients with these disorders had a fivefold to sixfold higher prevalence of hepatitis B
 antigen than healthy persons. Given the important public health problems of this disease in
 Taiwan and the rest of the Third World, this trial sought to answer the important question of
 whether hepatitis B immune globulin with a high level of antibody against the antigen would
 be of utility in combating the problem.

 Two hundred and five babies were accepted into the study, which was actually conducted on
 Taiwan through a contract to the Community Blood Council of Greater New York. Only those
 babies born of mothers who had HBsAg complement fixation titers of 1:8 or greater were
 included in these studies. At birth, blood was obtained from the mothers and cord blood from
 the infants. Follow-up bloods were obtained from both the mother and baby when the infants
 were 1, 3, 6, 12, 24 and 36 months of age. In addition, all household family contacts were
 bled at least once during this period.

 DESIGN NARRATIVE:

 Randomized, double-blind, fixed sample. A total of 205 neonates were assigned to treatment
 with high-titer hepatitis B immune globulin, standard immune globulin, or albumin placebo
 within 72 hours of delivery.

 The study completion date listed in this record was obtained from the Query/View/Report (QVR)
 System.
Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface
 antigen carriers.