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Understanding Poor Vaccine Responses to Hepatitis B Vaccination

StatusActive, Not Recruiting
PhasePhase 4
Started2022-07-07
View on ClinicalTrials.gov ↗
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.

Amendment history

2025-12-09
minor
Study Status, Document Section v7
Re-verified, no change to tracked fields
2025-12-03
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 200→confirmed 101
Study sitesdetails revised at 1 of 1 site
2025-01-28
minor
Study Status v5
Re-verified, no change to tracked fields
2024-03-26
minor
Study Status v4
Primary completion date2025-09→2026-07
Completion date2026-09→2026-07
2023-05-23
minor
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
Show 2 earlier versions
2022-07-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-12→confirmed 2022-07-07
Study sitesdetails revised at 1 of 1 site
2021-11-04
minor
Study Status v1
Primary completion date2025-01→2025-09
Completion date2026-01→2026-09
Start date2021-03→2021-12
2020-12-14
minor
Original filing
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.
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