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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
52
Subcutaneous fat injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
Intramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States
Hepatitis B surface antibody (HBsAb) titers (in international units/L)
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
Time frame: two years
Cell-mediated immune responses (CMI) (levels of interferon gamma and other cytokines in pg/ml)
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
Time frame: two years
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