Hepatitis B VaccinationEarly Phase 1NCT04162223
Hepatitis B Vaccine in Seniors
A Early Phase 1 study testing Subcutaneous fat injection of Recombivax-HB and Intramuscular injection of Recombivax-HB in people with Hepatitis B Vaccination, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Vaccination
- What is being tested?
- Subcutaneous fat injection of Recombivax-HB and Intramuscular injection of Recombivax-HB
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2000to 20 May 2003
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
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)
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.
- Conditions
- Hepatitis B Vaccination
- Being tested
- Subcutaneous fat injection of Recombivax-HB, Intramuscular injection of Recombivax-HB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Intramuscular injection of Recombivax-HBBiological
Intramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Fat Vaccine Injection | Experimental | Subcutaneous fat Hepatitis B vaccine injections on Days 0, 28, and 180. Receives: Biological: Subcutaneous fat injection of Recombivax-HB |
| Intramuscular Vaccine Injection | Experimental | Intramuscular Hepatitis B vaccine injections on Days 0, 28, and 180. Receives: Biological: Intramuscular injection of Recombivax-HB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start29 Mar 2000
- Primary completion20 May 2003
- Study completion20 May 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VaccinationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Sztein, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162223
- Sponsor's protocol ID
- 0199221
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32355503
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04162223
- Acronym / sponsor ID
- 0199221
- Conditions
- Hepatitis B Vaccination
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 29 Mar 2000 (actual)
- Primary completion
- 20 May 2003 (actual)
- Study completion
- 20 May 2003 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Fat Vaccine Injection | Experimental | Biological: Subcutaneous fat injection of Recombivax-HBSubcutaneous fat Hepatitis B vaccine injections on Days 0, 28, and 180. |
| Intramuscular Vaccine Injection | Experimental | Biological: Intramuscular injection of Recombivax-HBIntramuscular Hepatitis B vaccine injections on Days 0, 28, and 180. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous fat injection of Recombivax-HBSubcutaneous fat injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180. | Biological | Subcutaneous Fat Vaccine Injection |
| Intramuscular injection of Recombivax-HBIntramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180. | Biological | Intramuscular Vaccine Injection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Derived from this study: PubMed 32355503Edelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Subcutaneous fat injection of Recombivax-HB and Intramuscular injection of Recombivax-HB in people with Hepatitis B Vaccination, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis B surface antibody (HBsAb) titers (in international units/L) (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.