Vaccination to study immune response in healthy volunteers
HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers
This study is testing how the Hepatitis B vaccine affects the immune system in healthy adults to see if it can help create stronger protection against infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Rockefeller University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05272735 on ClinicalTrials.gov |
What this trial studies
This study evaluates how the immune system responds to the Hepatitis B vaccine by focusing on the role of germinal centers in the maturation of antibodies. It aims to understand the efficiency of memory B cells in forming new germinal centers upon receiving booster doses of the vaccine. By analyzing the immune response in healthy volunteers aged 18 to 50, the study seeks to provide insights into how vaccines can be optimized for better protection against infections. The research will involve administering the recombinant Hepatitis B vaccine and monitoring the participants' immune responses over time.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18 to 50 with no prior history of Hepatitis B infection or vaccination.
Not a fit: Patients with a history of Hepatitis B infection, HIV, chronic HCV infection, or significant allergic reactions to vaccines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccine strategies, leading to more effective immunization against Hepatitis B and potentially other viral infections.
How similar studies have performed: While the study explores a common assumption in vaccinology, recent findings in animal models suggest that the efficiency of memory B cells in forming secondary germinal centers may be less than previously thought, indicating a novel area of investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
New York, New York
- The Rockefeller University — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gabriel D. Victora, PhD — The Rockefeller University
- Study coordinator: Recruitment Specialist
- Email: RUCARES@rockefeller.edu
- Phone: 1-800-782-2737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.