NCT04199715 is a Phase 1 clinical trial of Heplisav-B in Hepatitis B, sponsored by Baylor Research Institute.

Who is sponsoring NCT04199715?

NCT04199715 is sponsored by Baylor Research Institute.

What drugs are being tested in NCT04199715?

Interventions in NCT04199715: Heplisav-B.

What condition does NCT04199715 study?

NCT04199715 studies Hepatitis B.

Is NCT04199715 still recruiting?

NCT04199715 is currently completed. Last updated 11 March 2022.

Last reviewed 2022-03-11 · How we verify

NCT04199715

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

Completed Phase 1 Last updated 11 March 2022

What this trial tests

Phase 1 trial testing Heplisav-B in Hepatitis B in 10 participants. Completed in 20 January 2022.

Timeline

3 December 2019

Primary endpoint
20 January 2022

20 January 2022

Quick facts

Lead sponsor	Baylor Research Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	10
Start date	3 December 2019
Primary completion	20 January 2022
Estimated completion	20 January 2022
Sites	1 location across United States

Drugs / interventions tested

Heplisav-B

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Baylor Research Institute

Who can join

18 and older, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Vaccination with HepB-CpG vaccine in individuals undergoing immune suppressive drug therapy.
Perrillo R, Garrido LF, Ma TW, Rahimi R, et al · · 2023 · cited 8× · PMID 37353450 · DOI 10.1016/j.vaccine.2023.06.041

Verify or expand the search:

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Baylor Research Institute trials

Trials by the same sponsor.

NCT07467720 — Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial · NA · not yet recruiting
NCT07547878 — Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) · Phase 4 · not yet recruiting
NCT07460583 — ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes · NA · not yet recruiting
NCT07096544 — CALM Study: Cardiomems Assisted Lvad Management · NA · not yet recruiting
NCT07220395 — eHealth Literacy Intervention for Spanish Speaking Older Adults in the US · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04199715 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baylor Research Institute
Last refreshed: 11 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04199715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing