Simple combo could stop hepatitis b passed from mom to baby

NCT ID NCT05705427

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

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.

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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

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