Recruitment

Recruitment Status
Completed
Estimated Enrollment
8

Inclusion Criteria

Healthy volunteer without significant medical problems
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

Exclusion Criteria

History of Hepatitis B infection
Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
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
...
History of Hepatitis B infection
Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
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
Male or female < 18 and > 60 years of age
Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
Is pregnant or lactating
Received any vaccine within a month prior to study vaccine
In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
Unable to continue participation for 30 weeks
History of Hepatitis C virus (HCV) infection or positive HCV antibody test
human immunodeficiency virus (HIV) positive
History of previous Hepatitis B vaccination(s)
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

Healthy volunteer without significant medical problems
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

Exclusion Criteria

History of Hepatitis B infection
Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
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
...
History of Hepatitis B infection
Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
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
Male or female < 18 and > 60 years of age
Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
Is pregnant or lactating
Received any vaccine within a month prior to study vaccine
In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
Unable to continue participation for 30 weeks
History of Hepatitis C virus (HCV) infection or positive HCV antibody test
human immunodeficiency virus (HIV) positive
History of previous Hepatitis B vaccination(s)
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