NCT04162223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2000

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2000

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2003

Completed
16.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

3.1 years

First QC Date

October 31, 2019

Last Update Submit

November 12, 2019

Conditions

Hepatitis B Vaccination

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    two years

Study Arms (2)

Subcutaneous Fat Vaccine Injection

EXPERIMENTAL

Subcutaneous fat Hepatitis B vaccine injections on Days 0, 28, and 180.

Biological: Subcutaneous fat injection of Recombivax-HB

Intramuscular Vaccine Injection

EXPERIMENTAL

Intramuscular Hepatitis B vaccine injections on Days 0, 28, and 180.

Biological: Intramuscular injection of Recombivax-HB

Interventions

Subcutaneous fat injection of Recombivax-HBBIOLOGICAL

Subcutaneous fat injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.

Subcutaneous Fat Vaccine Injection
Intramuscular injection of Recombivax-HBBIOLOGICAL

Intramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.

Intramuscular Vaccine Injection

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Edelman R, Deming ME, Toapanta FR, Heuser MD, Chrisley L, Barnes RS, Wasserman SS, Blackwelder WC, Handwerger BS, Pasetti M, Siddiqui KM, Sztein MB. The SENIEUR protocol and the efficacy of hepatitis B vaccination in healthy elderly persons by age, gender, and vaccine route. Immun Ageing. 2020 Apr 28;17:9. doi: 10.1186/s12979-020-00179-9. eCollection 2020.

    PMID: 32355503DERIVED

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Medicine, Microbiology and Immunology

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 14, 2019

Study Start

March 29, 2000

Primary Completion

May 20, 2003

Study Completion

May 20, 2003

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations

US(1)