Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B; Hepatitis, Viral, Human; Liver Diseases
Intervention: immunoglobulins, intravenous (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Summary
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.
Clinical Details
Study design: Prevention, Randomized, Double-Blind, Placebo Control
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface
antigen carriers.
Locations and Contacts
Additional Information
Related publications: Beasley RP, Stevens CE: Vertical Transmission of HBV and Interruption with Globulin, in Vyas GN, Cohen SN, Schmid R (eds.), Viral Hepatitis: A Contemporary Assessment of Etiology, Epidemiology, Pathogenesis and Prevention. Philadelphia, Franklin Institute Press, 1978, 333-345. Stevens CE, Neurath RA, Beasley RP, Szmuness W. HBeAg and anti-HBe detection by radioimmunoassay: correlation with vertical transmission of hepatitis B virus in Taiwan. J Med Virol. 1979;3(3):237-41.
Starting date: November 1975
Last updated: June 23, 2005
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