Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Status:
Active, not recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant
women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last
trimester of pregnancy and for two months following delivery. Their infants will receive
hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize
that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of
the study will help define policy to manage HBV infected pregnant women to prevent perinatal
transmission.
Phase:
Phase 3
Details
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
Chiang Mai University Ministry of Health, Lao PDR Ministry of Health, Thailand