Duration of Long-term Immunity After Hepatitis B Virus Immunization

NCT01182311 | Completed

• 2 other identifiers: 10018710-DK-0187
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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, 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 samples to test for hepatitis B antibodies and other immune system studies.
• Participants will receive a letter or phone call with the results of the blood tests:
• Those who no longer have protective levels of antibody against the hepatitis B virus will be offered a booster dose of the hepatitis B vaccine. To monitor immune response to the booster vaccine, additional study visits will be scheduled at 1 and 3 weeks following the booster.
• Those who have chronic infection with the hepatitis B virus will be advised to follow up with their primary care physician, and may be eligible to participate in ongoing treatment trials for chronic hepatitis B.
• Those who have abnormal blood tests will be referred back to their primary care physician for investigation of the abnormal tests results, and may also be referred to other National Institutes of Health protocols.
• Additional tests will evaluate immune response to the measles, mumps, and rubella (German measles) viruses. Some participants may be advised to have an additional MMR vaccine through their primary care physician.

Conditions

Hepatitis B

Keywords

Hepatitis B Virus; Hepatitis B Vaccine; Immunity; B-Cell Response; T-Cell Response; Hepatitis B Immunity; Hepatitis B Virus Vaccine

Outcome Measures

Primary Outcomes (1)

• Protective Anti-HBs

  Anti-HBs levels \>12 mIU/mL

  At start of study

Secondary Outcomes (2)

• HBV-specific antibodies

  At start of study

• Quantitative assessment of HBV-specific memory B cells and T

  At start of study

Study Arms (6)

Controls

Never received HBV vaccine and never had HBV

HIV vaccinated >= 10 years

Well compensated HIV disease, vaccinated HBV \>= 10 years ago

Spontaneously recovered >= 10 years

Spintaneously recovered from acute HBV \>= 10 years ago

Vaccinated >= 20 years

Vaccinated against HBV \>= 20 years ago

Vaccinated 10 < 15 years

Vaccinated against HBV 10 \< 15 years ago

Vaccinated 15 < 20 years

Vaccinated against HBV 15 \< 20 years ago

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital employees

You may qualify if:

• 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
• CD4 count of great than or equal to 250 /mm3 at time of vaccination
• Known HIV infection at time of vaccination

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Dienstag JL. Hepatitis B virus infection. N Engl J Med. 2008 Oct 2;359(14):1486-500. doi: 10.1056/NEJMra0801644. No abstract available.

  PMID: 18832247 BACKGROUND

• Kim WR. Epidemiology of hepatitis B in the United States. Hepatology. 2009 May;49(5 Suppl):S28-34. doi: 10.1002/hep.22975.

  PMID: 19399791 BACKGROUND

• McQuillan GM, Coleman PJ, Kruszon-Moran D, Moyer LA, Lambert SB, Margolis HS. Prevalence of hepatitis B virus infection in the United States: the National Health and Nutrition Examination Surveys, 1976 through 1994. Am J Public Health. 1999 Jan;89(1):14-8. doi: 10.2105/ajph.89.1.14.

  PMID: 9987458 BACKGROUND

• Gara N, Abdalla A, Rivera E, Zhao X, Werner JM, Liang TJ, Hoofnagle JH, Rehermann B, Ghany MG. Durability of antibody response against hepatitis B virus in healthcare workers vaccinated as adults. Clin Infect Dis. 2015 Feb 15;60(4):505-13. doi: 10.1093/cid/ciu867. Epub 2014 Nov 10.

  PMID: 25389254 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Marc G Ghany, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 16, 2010
• Study Start: September 8, 2010
• Primary Completion: May 1, 2013
• Study Completion: December 9, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

US (1)