Hepatitis B Vaccine in Seniors
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|ClinicalTrials.gov Identifier: NCT04162223|
Recruitment Status : Completed
First Posted : November 14, 2019
Last Update Posted : November 14, 2019
The first purpose of this study is to test the body's protective reaction (making antibodies) to a licensed hepatitis B vaccine (Recombivax-HB) after it is injected either in the arm fat or muscle. Hepatitis B virus is an important cause of liver disease in humans. More than 21% of healthy adults over age 60 years demonstrate evidence of previous Hepatitis B infection using a common blood test.
The second purpose of this study is to learn more information about other reasons (such as body fat content, gene types, etc.), why older people respond less well than younger people to vaccines. The Investigators will also learn more about the ability of certain white blood cells, called T cells, to respond to protein signals in the blood. T cells do not seem to respond as well to these protein signals as individuals age. The Investigators will compare results to a younger group of volunteers who have also been vaccinated with hepatitis B vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B Vaccination||Biological: Subcutaneous fat injection of Recombivax-HB Biological: Intramuscular injection of Recombivax-HB||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Immunosenescence: A Single-Blinded Comparison of the Location of Vaccine Inoculum, Intramuscular Versus Subcutaneous Adipose Tissue, on the Immune Response of Healthy Elderly Adults to a Recombinant Hepatitis B Surface Antigen Vaccine (Recombivax-HB)|
|Actual Study Start Date :||March 29, 2000|
|Actual Primary Completion Date :||May 20, 2003|
|Actual Study Completion Date :||May 20, 2003|
Experimental: Subcutaneous Fat Vaccine Injection
Subcutaneous fat Hepatitis B vaccine injections on Days 0, 28, and 180.
Biological: Subcutaneous fat injection of Recombivax-HB
Subcutaneous fat injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
Experimental: Intramuscular Vaccine Injection
Intramuscular Hepatitis B vaccine injections on Days 0, 28, and 180.
Biological: Intramuscular injection of Recombivax-HB
Intramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
- Hepatitis B surface antibody (HBsAb) titers (in international units/L) [ Time Frame: two years ]Basic science - Primary and booster hepatitis B surface antibody titers to three injections of Recombivax-HB in the elderly and young adults immunized subcutaneously or intramuscularly, including % responders
- Cell-mediated immune responses (CMI) (levels of interferon gamma and other cytokines in pg/ml) [ Time Frame: two years ]Basic science - Primary and booster CMI responses to three injections of Recombivax-HB in the elderly and young adults immunized subcutaneously or intramuscularly, including % responders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162223
|United States, Maryland|
|University of Maryland, Baltimore, Center for Vaccine Development and Global Health|
|Baltimore, Maryland, United States, 21201|