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Simple combo could stop hepatitis b passed from mom to baby

NCT ID NCT05705427

Prevention Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving pregnant women with hepatitis B a daily pill (tenofovir) plus giving their newborns a hepatitis B vaccine at birth could safely prevent the virus from passing to the baby. The trial enrolled 317 women in the Democratic Republic of Congo and followed them and their infants for six months after birth. The main goals were to see if the approach was safe, acceptable, and feasible in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenofovir Disoproxil Fumarate (TDF) and hepatitis B birth-dose vaccine
What this could lead to
If this approach works, it could offer a simple, affordable way to prevent mother-to-child transmission of hepatitis B in low-resource settings.
What could go wrong
This is a feasibility trial, not designed to prove effectiveness. The results may not apply to other regions or populations, and side effects from tenofovir are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

317 people

The number who actually took part.

Started

Aug 2023

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women ≥18 years of age who present for routine prenatal care between 28-32 weeks' gestation and who test HBV-positive by point-of-care hepatitis B surface antigen test. Women must intend to seek maternity and postpartum care exclusively at one of the Kinshasa-based study maternity centers. * Infants born to enrolled women will be included in the study Exclusion Criteria: * Individuals with abnormal creatinine by point-of-care testing * Any woman who plans to move outside of Kinshasa Province during the study period. * Any HIV-positive individual, determined by routine point-of-care screening at antenatal care visits

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B Vertical transmission of infectious disease

Contacts and locations

Locations

  • Université Protestant au Congo

    Kinshasa, Democratic Republic of the Congo

More trials for these conditions

Other studies related to the condition(s) this trial covers.