Status:
RECRUITING
HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Hepatitis B
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 ca...
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 ne...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
December 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05272735
Start Date
December 10 2022
End Date
December 31 2026
Last Update
March 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Rockefeller University
New York, New York, United States, 10065