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HepTcell hepatitis b vaccine trial ends early: what it means

NCT ID NCT04684914

Disease control Sponsor: Altimmune, Inc. 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 a treatment called HepTcell, which is like a vaccine that trains the immune system to fight the hepatitis B virus. It was for people with inactive chronic hepatitis B who had not received treatment before. The goal was to see if it could lower virus levels or clear the virus from the blood. The trial was ended early, so results are limited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

87 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 years

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: * Men and women 18 to 65 years of age, inclusive * Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1 * qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening * HBV DNA ≥ 10 IU/mL at screening * AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening Exclusion Criteria: * Positive hepatitis B e antigen (HBeAg) at screening * History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months * Undetectable HBV DNA at screening * Fibroscan \> 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis \[F1 or greater\] was identified).

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B, chronic

Contacts and locations

Locations

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73071, United States

  • Consorcio Hospital General Universitario De Valencia

    Valencia, 46014, Spain

  • Goethe University Hospital

    Frankfurt am Main, 60590, Germany

  • Hospital Clínic De Barcelona

    Barcelona, 08028, Spain

  • Hospital Nuestra Señora De Valme

    Seville, 41014, Spain

  • Hospital Universitari I Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Paragon Rx Clinical

    Garden Grove, California, 92840, United States

  • Queens Medical Center

    Nottingham, NG7 2UH, United Kingdom

  • San Jose Gastroenterology Institute

    San Jose, California, 95128, United States

  • St. Georges University of London

    London, SW17 0RE, United Kingdom

  • St. Mary's Hospital

    London, W2 1NY, United Kingdom

  • Stanford University Department of Medicine

    Redwood City, California, 94063, United States

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN

    Toronto, Ontario, M5G 2C4, Canada

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Calgary Liver Unit - Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6, Canada

  • Univesritätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

More trials for these conditions

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