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NCT04162223 · ClinicalTrials.gov registry record · Early Phase 1
Hepatitis B Vaccine in Seniors
A Early Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 52
- Enrollment target
NCT04162223: Completed Early Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT04162223 is a Early Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 52 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04162223, a Early Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BIOLOGICAL Subcutaneous fat injection of Recombivax-HB
- BIOLOGICAL Intramuscular injection of Recombivax-HB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2000-03-29 |
| Est. Completion | 2003-05-20 |
| Phase | Early Phase 1 |
What the finished NCT04162223 record still lists
NCT04162223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Subcutaneous fat injection of Recombivax-HB is the first listed.
NCT04162223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04162223 about?
NCT04162223 is a clinical study titled "Hepatitis B Vaccine in Seniors". 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 ov...
What is the current status of trial NCT04162223?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 52 participants. The study started on 2000-03-29. Estimated completion is 2003-05-20.
What interventions are being tested in trial NCT04162223?
The interventions under investigation include: Subcutaneous fat injection of Recombivax-HB (BIOLOGICAL), Intramuscular injection of Recombivax-HB (BIOLOGICAL).
Who is sponsoring clinical trial NCT04162223?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04162223's enrollment target sits among peer trials
52 477th of 2000 higher than 1,515 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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