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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT01182311 |
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Date of registration:
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13/08/2010 |
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Primary sponsor: |
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Public title:
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Duration of Long-term Immunity After Hepatitis B Virus Immunization
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Scientific title:
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Duration of Long-Term Immunity After Hepatitis B Virus Immunization |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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190 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01182311 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Marc G Ghany, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Key inclusion & exclusion criteria
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- 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
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
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. History of bone marrow or stem cell transplant
10. History of organ transplant
11. Known underlying immune suppressive condition
12. 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis B
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Secondary ID(s)
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10-DK-0187
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100187
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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