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Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000580
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Hepatitis, Viral, Human Liver Diseases Drug: immunoglobulins, intravenous Phase 3

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : November 1975
Actual Study Completion Date : June 1986

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface antigen carriers.
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.

Layout table for additonal information Identifier: NCT00000580    
Other Study ID Numbers: 300
P01HL009011-18A1 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: January 2000
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs