Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin
(HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from
hepatitis B virus (HBV) infection. However, hepatitis B infection due to immunoprophylaxis
failure often occurs in approximately 10% of infants who are born to highly viremic mothers
with HBeAg-positive. Maternal HBV DNA > 200,000 IU/mL is the major independent risk for
mother-to-child transmission (MTCT). A recent randomized controlled trial has shown that
Tenofovir Disoproxil Fumarate (TDF) use during the third trimester of pregnancy could safely
reduce the rate of MTCT with few adverse effects when combined with the administration of the
standard immunoprophylaxis to the infants. However, HBIg is expensive and not available in
many developing countries, resulting approximately 30% of infant infection when they received
only HBV vaccination. The present study aims to investigate if highly viremic mothers who are
treated with TDF from the second trimester to delivery in combination of infant's standard
series of HBV vaccinations (omission of HBIg) have a comparable MTCT rates, when compared to
those of mothers who receive TDF at the third trimester in combination of infant's standard
HBV vaccinations and a birth dose of HBIg.