Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 8
Inclusion Criteria
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
- Healthy volunteer without significant medical problems
Exclusion Criteria
- Unable to continue participation for 30 weeks
- Received any vaccine within a month prior to study vaccine
- History of previous Hepatitis B vaccination(s)
- ...
- Unable to continue participation for 30 weeks
- Received any vaccine within a month prior to study vaccine
- History of previous Hepatitis B vaccination(s)
- In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- Is pregnant or lactating
- Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- human immunodeficiency virus (HIV) positive
- Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
- History of Hepatitis B infection
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- Male or female < 18 and > 60 years of age
- Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
Summary
- Conditions
- Hepatitis B
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions acti...
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Inclusion Criteria
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
- Healthy volunteer without significant medical problems
Exclusion Criteria
- Unable to continue participation for 30 weeks
- Received any vaccine within a month prior to study vaccine
- History of previous Hepatitis B vaccination(s)
- ...
- Unable to continue participation for 30 weeks
- Received any vaccine within a month prior to study vaccine
- History of previous Hepatitis B vaccination(s)
- In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- Is pregnant or lactating
- Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- human immunodeficiency virus (HIV) positive
- Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
- History of Hepatitis B infection
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- Male or female < 18 and > 60 years of age
- Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
Tracking Information
- NCT #
- NCT02055365
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Brad Rosenberg, MD, PhD The Rockefeller University
- Brad Rosenberg, MD, PhD The Rockefeller University
Get Well Soon