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Main
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Note: This record shows only 22 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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11 January 2021 |
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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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Prospective Registration:
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Yes |
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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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September 8, 2010 |
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Target sample size:
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205 |
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Recruitment status: |
Completed |
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URL:
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https://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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Phase:
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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 (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:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis B
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Primary Outcome(s)
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Protective Anti-HBs
[Time Frame: At start of study]
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Secondary Outcome(s)
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Quantitative assessment of HBV-specific memory B cells and T
[Time Frame: At start of study]
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HBV-specific antibodies
[Time Frame: At start of study]
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Secondary ID(s)
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100187
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10-DK-0187
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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