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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
The Rockefeller University
RECRUITING
New York
Contact Information
Primary
Recruitment Specialist
RUCARES@rockefeller.edu
1-800-782-2737
Time Frame
Start Date: 2022-12-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Hepatitis B Vaccine (Recombinant)
Hepatitis B Vaccine (Recombinant) 20 mcg intramuscular injection at 0-1-6 months
Sponsors
Collaborators: Weill Medical College of Cornell University
Leads: Rockefeller University

This content was sourced from clinicaltrials.gov