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NCT05272735
HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers
Phase 4 trial testing Hepatitis B Vaccine (Recombinant) in Hepatitis B in 9 participants. Terminated before completion.
29 September 2025
Quick facts
| Lead sponsor | Rockefeller University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 9 |
| Start date | 10 December 2022 |
| Primary completion | 29 September 2025 |
| Estimated completion | 29 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hepatitis B Vaccine (Recombinant) — full drug profile →
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
Rockefeller University
Who can join
Adults 18 to 50, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Antibodies are the primary mediators of the protection against infection provided by vaccination. Antibodies become most powerful after the B cells that produce them undergo an evolutionary process called affinity maturation, in which antibodies increase their ability to bind to their targets, and thus neutralize pathogens. Affinity maturation occurs in structures within secondary lymphoid organs (for example lymph nodes or tonsils) known as germinal centers. Germinal centers are well known to be triggered by the first dose of vaccines, generating affinity matured plasma cells (B cells that secrete antibody into serum) and memory B cells, which can be converted into plasma cells by booster doses of vaccine. However, it is not fully understood the extent to which memory B cells can return to germinal centers again upon vaccine boosting. Such return would be very important to allow B cells, for example, to adapt to emerging variants of viruses such as influenza or SARS-CoV-2. This study will involve acquiring samples of B cells from germinal centers that form in response to vaccination with the highly effective hepatitis B vaccine. These cells will be analyzed to determine what fraction of them are memory B cells that returned to germinal centers upon boosting, information that is key to knowledge of how vaccine boosters work. Understanding the "rules" that govern how and when memory B cells choose to return to germinal centers in an effective vaccine such hepatitis B could help efforts to develop effective vaccination against more challenging, rapidly mutating viruses, such as influenza, HIV, and hepatitis C.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Hepatitis B Vaccine (Recombinant)
Trials testing the same drug.
- NCT02055365 — Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers · NA · completed
- NCT00414050 — A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) · Phase 3 · completed
Other recruiting trials for Hepatitis B
Currently open trials in the same condition.
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- NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
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- 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 Rockefeller University trials
Trials by the same sponsor.
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- NCT06223035 — Myokine Identification Following Acute Exercise · NA · completed
- NCT06146218 — Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress · NA · completed
- NCT05856890 — HepB mAb19 in Individuals With Chronic Hepatitis B Infection · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05272735 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rockefeller University
- Last refreshed: 16 April 2026
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/NCT05272735.
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