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Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Sponsor: Institut de Recherche pour le Developpement
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.
Official title: A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
504
Start Date
2018-08-02
Completion Date
2025-06-30
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Anti-HBV antiviral prophylaxis
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
Locations (20)
Champasak Hospital
Champasak, Laos
Luang Prabang Provincial Hospital
Luang Prabang, Laos
Sayaboury Hospital
Sainyabuli, Laos
Savannakhet Provincial hospital
Savannakhet, Laos
103 Hospital
Vientiane, Laos
Mahosot Hospital
Vientiane, Laos
Mother and Newborn Hospital
Vientiane, Laos
Setthathirath Hospital
Vientiane, Laos
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, Thailand
Nopparat Rajathanee Hospital
Bangkok, Thailand
Prapokklao Hospital
Chanthaburi, Thailand
Health Promotion Center Region 1
Chiang Mai, Thailand
Nakornping Hospital
Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Chonburi Hospital
Chon Buri, Thailand
Banglamung Hospital
Chon Buri, Thailand
Lampang Hospital
Lampang, Thailand
Lamphun Hospital
Lamphun, Thailand
Samutprakarn Hospital
Mueang Samut Prakan, Thailand
Samutsakhon Hospital
Samut Sakhon, Thailand