Clinical Trial

Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Active, Not Recruiting Phase 4
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Record status
This record was last updated December 15, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood. This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-12-14; most recent amendment 2025-12-09.
Status change: Recruiting → Active, Not Recruiting 2025-12-03
Status change: Not Yet Recruiting → Recruiting 2022-07-08
Trial Details
NCT Number NCT04674462
Lead Sponsor NYU Langone Health
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Vaccine Reaction
Enrollment 101 participants
Start Date 2022-07-07
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-15