Hepatitis B Vaccine in Seniors

November 12, 2019 updated by: Marcelo Sztein, University of Maryland, Baltimore

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years
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
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2000

Primary Completion (ACTUAL)

May 20, 2003

Study Completion (ACTUAL)

May 20, 2003

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (ACTUAL)

November 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0199221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B Vaccination

Clinical Trials on Subcutaneous fat injection of Recombivax-HB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe