AzTrials
AzTrials

Hepatitis BPhase 4NCT05272735

HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers

A Phase 4 study testing Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Rockefeller University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B
What is being tested?
Hepatitis B Vaccine (Recombinant)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
10 Dec 2022to 29 Sep 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and females
  • Age 18-50 years Note: The HBV vaccine dose will be adjusted according to the Package Insert for participants who are 18 and 19 years of age.
  • No prior history of HBV infection or vaccination.

Who cannot join

  • HBV seropositivity (e.g. HBsAb, HBcAb or HBeAb)
  • HIV infection
  • Chronic HCV infection
  • Pregnancy or lactation
  • History of allergic reaction to any components of the HBV vaccine
  • History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration)
Show all 13Show fewer
  • Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the Investigator within the previous 6 months; Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study
  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the volunteer unsuitable for participation in the study
  • Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy or platelet disorder that requires special precautions)
  • Laboratory abnormalities:
  • Platelets <125,000 cells/mm3 PT/INR >1.3 PTT > 2 x ULN
  • Receipt of live attenuated or mRNA vaccine within the previous 30 days or planned receipt within 30 days after IP administration; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after IP administration
  • Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Rockefeller University

    New York, New York, 10065

Other trials in United States

About this study

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.

Read the detailed description

A feature of the immune system of critical importance is its ability to mount a much stronger antibody response the second time a pathogen or antigen is encountered (1). This property underlies the need for "booster" doses to ensure the effectiveness of vaccination. The booster effect derives in part from the generation, by the primary response, of expanded clones of memory B cells (MBCs). Upon re-exposure to antigen, MBCs rapidly proliferate and differentiate into plasma cells, generating high titers of serum antibody over a short period of time. Because most MBCs that respond to boosting have also undergone affinity maturation in germinal centers (GCs) during the primary response (2), MBC-derived antibody has both higher affinity and higher cross-variant breadth than primary antibody (3).

A common assumption in the vaccinology field has been that, in addition to forming plasma cells, MBCs will also generate secondary GCs upon boosting with high efficiency, allowing them to re-evolve their immunoglobulins to adapt to variant strains of a pathogen (4-6). This assumption forms the basis of multiple attempts to guide B cell clones towards broad reactivity to influenza or HIV by iteratively recruiting them to germinal centers by sequential immunization.

Recent work using genetic tracing of memory B cell clones in mice questions this assumption (7). Using fate-mapping of primary-GC-derived B cells, results showed that mouse MBCs are remarkably inefficient at forming secondary GCs, which instead consist predominantly (>90%) of cells derived from naïve precursors engaged only by the boost but not by the prime (2). Partly in contrast to the mouse findings, a recent study using fine-needle aspirates (FNA) to sample vaccine-draining lymph node GCs in healthy humans immunized with a quadrivalent influenza vaccine showed that MBC participation in recall GCs can vary depending on the individual sampled, ranging from approximately 5%, a proportion similar to that found in mice, to up to ~65% in one individual (8). This wide range was not recapitulated in our mouse models. A key unknown in this study was the degree of prior exposure of each individual to influenza antigens, via either infection or vaccination. Long histories of exposure can generate influenza-specific MBC compartments in blood that represent >1% of all B cells (9). On the other hand, simpler exposure regimens, such as HPV, tetanus, and HBV vaccination, generate much lower frequencies of antigen-specific MBCs, in the high tens to low hundreds per million B cells, comparable to frequencies found after single immunization or infection in mice (10-14).

There is a hypothesize that the wide range of MBC re-entry into recall GCs observed after human influenza vaccination reflects differences in the history of exposure of individuals to influenza antigens, rather than more fundamental differences in MBC biology between humans and mice. There is expectation the findings of this study will be of critical value to the general understanding of vaccination, as well as to those seeking to generate influenza and HIV broadly neutralizing antibodies (bNAbs) by vaccination. These studies will also be critical to determine the extent to which mouse models reliably predict human responses at the clonal level and can therefore be used to test sequential immunization regimens.

Conditions
Hepatitis B
Being tested
Hepatitis B Vaccine (Recombinant)
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatitis B Vaccine (Recombinant)Biological

    Hepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months

Study groups in NCT05272735
Study groupRoleWhat they receive
Hepatitis B Vaccine (Recombinant)ExperimentalHepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months
Receives: Biological: Hepatitis B Vaccine (Recombinant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effects of HBV Vaccine on Memory B Cells

    The percentage of B cells in GCs triggered by the third dose of HBV vaccine that can derive from memory B cells.

    Measured: 6 months

Secondary outcomes (1)
  1. B Cell Response to the HBV Vaccination

    The percentage and characterization of the clonal and cellular dynamics of the B cell response to the three-dose sequence of HBV vaccination.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start10 Dec 2022
  3. Primary completion29 Sep 2025
  4. Study completion29 Sep 2025

Why it stopped: The yield of cells recovered from the lymph node fine needle aspirations was low limiting the ability to perform the planned immunologic assessments following HBV vaccination.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272735
Sponsor's protocol ID
GVI 1028
Status last verified
Apr 2026
First submitted
28 Feb 2022
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mesin L, Schiepers A, Ersching J, Barbulescu A, Cavazzoni CB, Angelini A, Okada T, Kurosaki T, Victora GD. Restricted Clonality and Limited Germinal Center Reentry Characterize Memory B Cell Reactivation by Boosting. Cell. 2020 Jan 9;180(1):92-106.e11. doi: 10.1016/j.cell.2019.11.032. Epub 2019 Dec 19.

    PubMed 31866068

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Rockefeller University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The yield of cells recovered from the lymph node fine needle aspirations was low limiting the ability to perform the planned immunologic assessments following HBV vaccination.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effects of HBV Vaccine on Memory B Cells (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in