Testing a hepatitis E vaccine in children and adults

Plain-English translation of NCT06306196 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing Hecolin®, a vaccine designed to protect against hepatitis E virus infection. Researchers want to see how well the vaccine works and how safe it is when given to children as young as 2 years old and to adults, including those living with HIV. The vaccine is given as three shots spaced over 6 months.

Hepatitis E is a serious liver disease that can affect people worldwide, but there is limited information about how well this medication protects children compared to adults. This trial will help doctors understand the best way to use the vaccine across different age groups, including vulnerable populations like people with HIV.

Do you qualify?

You likely qualify if…

you are between 2 and 45 years old at the time you enroll
you are in good overall health
you are HIV-negative (with some groups specifically enrolling HIV-positive adults)
you have never received a hepatitis E vaccine before
you are willing to receive three vaccine injections over 6 months and return for follow-up visits
you agree to use effective birth control if you are a woman or non-sterile man of childbearing potential

You likely don't qualify if…

you have a fever or acute illness within 3 days before vaccination
you have a known allergy to any component of the vaccine
you have a bleeding disorder or condition that makes intramuscular injections unsafe
you are taking immunosuppressive medications or have an immune disorder (with some exceptions for HIV-positive adults)
you have received other vaccines within 4 weeks before or plan to receive them within 4 weeks after the study vaccine

What participation looks like

You would receive either three vaccine shots or a combination of shots and placebo (dummy shots) given at baseline, 1 month, and 6 months. Between shots, you'll have follow-up visits where blood samples are taken to measure your immune response. The entire study lasts about 7 months. Some participants (depending on their age group) will receive the full three-dose schedule, while others may receive two doses plus one placebo injection.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Testing a hepatitis E vaccine in children and adults

What is this trial?

Do you qualify?

What participation looks like

Trial locations