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NCT01182311 · ClinicalTrials.gov registry record
Duration of Long-term Immunity After Hepatitis B Virus Immunization
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 205
- Enrollment target
NCT01182311 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 205 participants.
The verdict
NCT01182311 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 205 participants
- Enrollment target
Study Summary
Background: * The hepatitis B vaccine has been shown to be safe and effective in preventing transmission of the hepatitis B virus. Response rates to the initial three doses of the vaccine are high, with significant or even complete immune response. However, this level has been reported to decline rapidly within the first year and more slowly thereafter. There is little data on the durability and long-term protection provided by the hepatitis B vaccine administered to adults in the United States. * Vaccinated individuals are believed to be protected against hepatitis B virus infection because of a memory immune response. Even if antibody levels are low, the immune system will still be able to produce enough antibody to neutralize the hepatitis B virus. Therefore, booster doses of the vaccine are not recommended, except for some high-risk individuals such as patients on dialysis. Researchers are interested in determining the durability of the immune response of the hepatitis B vaccine in adults with low or intermediate risk for hepatitis B virus infection. Objectives: \- To examine the long-term immune status of human immunodeficiency virus (HIV) positive and negative individuals who received the hepatitis B vaccine during adulthood, compared with the immune status of individuals who acquired natural immunity by recovering from acute hepatitis B during adulthood. Eligibility: * Individuals at least 18 years of age who were vaccinated against hepatitis B at least 10 years ago. * Individuals at least 18 years of age who contracted and recovered from acute hepatitis B at least 10 years ago. * Individuals at least 18 years of age who have well-controlled HIV and were vaccinated against hepatitis B at least 10 years ago. Design: * Participants will have a single outpatient study visit and potential follow-up visits as part of this protocol. * Participants will complete a questionnaire assessing possible risk factors for hepatitis B infection, and will provide blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2010-09-08 |
| Est. Completion | 2020-12-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01182311
The ClinicalTrials.gov registry entry for NCT01182311 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01182311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01182311 about?
NCT01182311 is a clinical study titled "Duration of Long-term Immunity After Hepatitis B Virus Immunization". Background: * The hepatitis B vaccine has been shown to be safe and effective in preventing transmission of the hepatitis B virus. Response rates to the initial three doses of the vaccine are high, with significant or even complete immune response. However, this level has been reported to decline r...
What is the current status of trial NCT01182311?
This trial is currently completed. The enrollment target is 205 participants. The study started on 2010-09-08. Estimated completion is 2020-12-09.
Who is sponsoring clinical trial NCT01182311?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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