Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus
1 other identifier
interventional
504
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2018
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMay 30, 2025
May 1, 2025
4.8 years
November 6, 2017
May 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infant hepatitis B infection status
HBsAg positive confirmed by PCR detection of HBV DNA.
Six months of age
Secondary Outcomes (8)
Maternal HBV DNA changes
From enrollment until end of study treatment scheduled 2 months after delivery
Infant levels of anti-HBs antibodies
At 1, 2, 4, 6, and 12 months of age
HBV infection status in all infants regardless of maternal response to study treatment
At 6 months of age
Serious adverse events
From enrollment until 12 months postpartum
Serious adverse events
From birth until 12 months of age
- +3 more secondary outcomes
Interventions
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
Eligibility Criteria
You may qualify if:
- Pregnancy
- Age ≥18 years
- Negative HIV antibody test during current pregnancy
- Positive HBsAg test during current pregnancy
- Positive HBeAg using a rapid test during current pregnancy
- Absence of clinical symptoms of liver disease
- Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
- Willing and able to provide written informed consent
- Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
- Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status
You may not qualify if:
- Receipt of anti-HBV antivirals at any time during the last 9 months
- Known liver cirrhosis or evidence of hepatocellular carcinoma
- Creatinine clearance \<50 ml/min, calculated using the Cockcroft-Gault formula
- Confirmed dipstick proteinuria \>1+ (\>30 mg/dL) or normoglycemic glycosuria
- Evidence of pre-existing fetal anomalies incompatible with life
- Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or compromise adherence to treatment and satisfactory follow up in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut de Recherche pour le Developpementlead
- Chiang Mai Universitycollaborator
- Ministry of Health, Thailandcollaborator
- Ministry of Health, Lao PDRcollaborator
Study Sites (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, 56110, Thailand
Nopparat Rajathanee Hospital
Bangkok, 10230, Thailand
Prapokklao Hospital
Chanthaburi, 22000, Thailand
Health Promotion Center Region 1
Chiang Mai, 50100, Thailand
Nakornping Hospital
Chiang Mai, 50180, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000, Thailand
Chonburi Hospital
Chon Buri, 20000, Thailand
Banglamung Hospital
Chon Buri, 20150, Thailand
Lampang Hospital
Lampang, 52000, Thailand
Lamphun Hospital
Lamphun, 51000, Thailand
Samutprakarn Hospital
Mueang Samut Prakan, 10280, Thailand
Samutsakhon Hospital
Samut Sakhon, 74000, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gonzague Jourdain, MD, PhD
Chiang Mai University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 17, 2017
Study Start
August 2, 2018
Primary Completion
May 13, 2023
Study Completion
June 30, 2025
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- At the same time as related publications
- Access Criteria
- See Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub or DASH
We are willing to share our data to answer important research questions requiring large datasets, after completion of the original research plan and substudies. Data-sharing agreements will include: an approval of the research plan by appropriate ethics committees, a commitment to using data for research purposes only and to securing the data or/and the samples using appropriate methods. Data used for publications will be released in a timely manner. De-identified study data will be accessible through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub or DASH (dash.nichd.nih.gov/). However, as of May 25, 2025, the DASH website will be unable to support new submissions for the next several months. The PI will submit the data when new submissions are open.