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Hepatitis B Vaccine in Seniors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162223
Recruitment Status : Completed
First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Marcelo Sztein, University of Maryland, Baltimore

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, community-dwelling adult men or women 65 years of age or older, of any race or ethnic group
  • Medical history with stable chronic non-immunologically mediated medical conditions (e.g. osteoarthritis, hypertension)
  • Normal (within the normal range for reference laboratory or clinically insignificant values as determined by the Principal Investigator) TSH, serum vitamin B12, AST/SGOT, ALT/SGPT
  • Negative serum tests for hepatitis B surface antigen and antibody, hepatitis B core antibody and hepatitis C antibody
  • Has given informed consent
  • Ready access to a telephone

Exclusion Criteria:

  • Clinically apparent or history of immunologically mediated diseases (e.g. rheumatoid arthritis, lupus erythematosis, etc.), immunodeficiency, severe cardiovascular disease, severe respiratory disease (requiring supplemental oxygen), endocrine disorder (e.g. thyroid dysfunction, adrenal insufficiency), liver disease (cirrhosis), renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder (eligible if treated and in remission), drug or alcohol abuse or currently smoking 10 cigarettes per day
  • Infections within 2 weeks of immunization (the most frequent infections are respiratory and urogenital)
  • Inflammatory processes such as known chronic infections, inflammatory bowel disease or Westergren sedimentation rate (greater than 50mm/hour for men, greater than 60mm/hour for women)
  • All malignancies (excluding non-melanotic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years
  • Arteriosclerotic event during the 2 weeks prior to enrollment (e.g. medically documented myocardial infarction, stroke, recanalization of the femoral arteries, claudication, or Transient Ischemic Attack (TIA))
  • Cardiac insufficiency, if heart failure present (New York Heart Association functional class III or IV)
  • Poorly controlled hypertension (Systolic Blood Pressure 180mmHg, Diastolic Blood Pressure 100mmHg on two separate determinations at least 10 minutes apart)
  • Renal Insufficiency (serum creatinine 2.0 or BUN 40) and stable over past 6 months
  • Elevated or low glucose (fasting 140 or less than 70, non-fasting 200)
  • Cognitive impairment: score of less than 23 on the Folstein Mini-Mental State Examination
  • Depression or mood alteration: score of 6 on the Geriatric Depression Scale
  • Malnutrition as defined by clinical judgment and by decreased serum albumin (less than 3.2g/L) or hypocholesterolemia (less than 160mg/dL), or low total lymphocyte count (less than 1500/ml3)
  • Anemia (Hct less than 30% or low serum vitamin B12 or vitamin E level)
  • History of or current alcoholism or consuming greater than 2oz of ETOH/day; current drug abuse; currently smoking 10 cigarettes per day
  • Risk factors for hepatitis B (which would indicate the need for immediate immunization with licensed vaccine), such as parenteral drug abuse, multiple sexual partners, commercial sex worker, health care worker
  • History of hepatitis B infection or vaccination
  • Positive test for hepatitis B surface antigen or antibody, hepatitis B core antibody, or hepatitis C antibody
  • History of significant bilateral upper arm injury or surgery, of any duration, because theoretically this may impede lymph drainage to regional lymph nodes
  • Reported allergy to thimerosal (i.e., contact lens solution) or yeast products
  • Unable to attend the Baltimore VA Medical Center or the Waxter Center on a regular basis; no telephone in primary residence
  • Subcutaneous fat pad less than 6 mm in thickness as determined by computer tomography
  • Medication exclusions include prednisone greater than 5 mg/day (or equal), colchicines, imuran, methotrexate, azathioprine, cyclophosphamide, cyclosporine, or interferons

Information from the National Library of Medicine

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


Locations
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United States, Maryland
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcelo Sztein, Professor of Pediatrics and Medicine, Microbiology and Immunology, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04162223    
Other Study ID Numbers: 0199221
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections