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NCT05272735 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Hepatitis B, sponsored by Rockefeller University.

Recruiting
Registry status
Phase 4
Development phase
12
Enrollment target
1
Study location

NCT05272735 is a Phase 4 study of Hepatitis B that is actively recruiting participants, run by Rockefeller University. The registered enrollment target is 12 participants, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05272735, a Phase 4 study of Hepatitis B, is actively recruiting participants, sponsored by Rockefeller University.

RECRUITING
Registry status
Phase 4
Development phase
12 participants
Enrollment target
1
Study location

Study 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 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.

Conditions Studied

Interventions

  • BIOLOGICAL Hepatitis B Vaccine (Recombinant)

Study Locations (1)

New York

  • The Rockefeller University - New York

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-12-10
Est. Completion 2026-12-31
Phase Phase 4

Sponsor

Rockefeller University

117 total trials

What the Registry Record Tells You About NCT05272735

The ClinicalTrials.gov registry entry for NCT05272735 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis B appearing as the primary indexed condition, and to 1 intervention - of which Hepatitis B Vaccine (Recombinant) is the first listed.

NCT05272735 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05272735 about?

NCT05272735 is a clinical study titled "HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers". 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 t...

What is the current status of trial NCT05272735?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-12-10. Estimated completion is 2026-12-31.

What conditions does trial NCT05272735 study?

This clinical trial studies the following conditions: Hepatitis B.

What interventions are being tested in trial NCT05272735?

The interventions under investigation include: Hepatitis B Vaccine (Recombinant) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05272735?

This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05272735 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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