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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 April 2014
Main ID:  NCT01182311
Date of registration: 13/08/2010
Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Public title: Duration of Long-term Immunity After Hepatitis B Virus Immunization
Scientific title: Duration of Long-Term Immunity After Hepatitis B Virus Immunization
Date of first enrolment: August 2010
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01182311
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Age 18 years or above and < 60 years when the first dose of hepatitis B vaccine
was administered

2. Male or female

3. 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)

4. 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.

5. For recovered patients, spontaneous recovery from acute hepatitis B must have
occurred prior to the year 2000

6. Willing and able to provide written, informed consent

Additional Inclusion Criteria for HIV positive cohort

1. CD4 count of great than or equal to 250 /mm3 at time of vaccination

2. Known HIV infection at time of vaccination

EXCLUSION CRITERIA:

1. History of chronic HBV infection

2. Incomplete HBV vaccine doses (with the exception of the 10 patients who were never
vaccinated and never infected with the hepatitis B virus)

3. Known non-response to an adequate course of hepatitis B vaccine

4. Received a booster dose of HBV vaccine

5. Current or recent (within the last 1 year) use of immunosuppressive/immuno-modifying
agents

6. Use of immunosuppressive/immuno-modifying agents at the time of vaccination

7. Renal failure with requirement for dialysis

8. Anti-HIV positive (Except for HIV positive cohort)

9. Anti-HCV positive

10. History of bone marrow or stem cell transplant

11. History of organ transplant

12. Known underlying immune suppressive condition

13. 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.

14. Anti-HBc positivity for the 10 patients who were never vaccinated and never infected
with the hepatitis B virus.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Hepatitis B
Intervention(s)
Primary Outcome(s)
To measure anti-HBs titers and immune response in HIV positive and negative adults who were vaccinated more than 10 years ago and to compare them to individuals who spontaneously recovered from acute hepatitis B more than 10 years ago
Secondary Outcome(s)
To assess the clinical, serological and immunological response to a booster dose of hepatitis B vaccine in those individuals who did not maintain the immune response to the primary vaccination.
Secondary ID(s)
10-DK-0187
100187
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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