Status:
COMPLETED
Duration of Long-term Immunity After Hepatitis B Virus Immunization
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Brief 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, w...
Detailed Description
Hepatitis B vaccine is very effective at preventing infection with the hepatitis B virus (HBV). Several studies have reported on the long-term efficacy of the HBV vaccine and indicate a decline in tit...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years or above and \< 60 years when the first dose of hepatitis B vaccine was administered
- Male or female
- Vaccination with 3 doses of either plasma-derived or recombinant HBV vaccine within one year (with the exception of the 10 patients who were never vaccinated and never infected with the hepatitis B virus)
- Vaccinated subjects must be able to provide written documentation indicating the dates of their hepatitis B immunization series. In the absence of written documentation, subjects will be asked to sign a written affidavit obtained either from themselves or their physician stating the date of vaccination accurate to one year and that they did not receive a booster dose to the best of their knowledge.
- For recovered patients, spontaneous recovery from acute hepatitis B must have occurred prior to the year 2000
- Willing and able to provide written, informed consent
- Additional Inclusion Criteria for HIV positive cohort
- CD4 count of great than or equal to 250 /mm3 at time of vaccination
- Known HIV infection at time of vaccination
- EXCLUSION CRITERIA:
- History of chronic HBV infection
- Incomplete HBV vaccine doses (with the exception of the 10 patients who were never vaccinated and never infected with the hepatitis B virus)
- Known non-response to an adequate course of hepatitis B vaccine
- Received a booster dose of HBV vaccine
- Current or recent (within the last 1 year) use of immunosuppressive/immuno-modifying agents
- Use of immunosuppressive/immuno-modifying agents at the time of vaccination
- Renal failure with requirement for dialysis
- Anti-HIV positive (Except for HIV positive cohort)
- Anti-HCV positive
- History of bone marrow or stem cell transplant
- History of organ transplant
- Known underlying immune suppressive condition
- Subjects with clinically significant anemia, hemoglobin \<10g/dL will be excluded from participating in the assessment of response to a booster dose of HBV vaccine until their hemoglobin is greater than or equal to12g/dL.
- Anti-HBc positivity for the 10 patients who were never vaccinated and never infected with the hepatitis B virus.
Exclusion
Key Trial Info
Start Date :
September 8 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01182311
Start Date
September 8 2010
End Date
December 9 2020
Last Update
December 11 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892