Tuesday, April 23, 2024

Titer Test Hepatitis B Vaccine

Hbig In Liver Transplantation

Titer Tests & Vaccines

HBIG is indicated to prevent reinfection in individuals who are undergoing liver transplantation due to hepatitis. If the HBIG is developed with indication for prevention of hepatitis B recurrence following liver transplantation then the clinical development to evaluate efficacy should be done in patients who have undergone liver transplant for liver failure caused by hepatitis B. In the same setting, additional data like antigen-driven complement fixation, opsonisation, phagocytosis, antibody-dependent cell mediated cytotoxicity may also be submitted. The new immunoglobulin for the above-said indication should be studied with at least 25 participants and also with the intended mode and route for administration. The European Medicines Agency accepts open-label uncontrolled studies for clinical development and also recommends to use end-points measuring the proportion of patients who develop a recurrence of hepatitis B as demonstrated by positive results for HBsAg and/or HBeAg, titer of anti-HBs, titer of circulating hepatitis B virus DNA, time to recurrence of hepatitis B, and overall survival.

I Received My Vaccine Years Ago

If it has been years since you have been vaccinated, you may need or may request a hepatitis B surface antibody titer blood test to confirm that you are still protected. A person is considered protected if they have a positive anti-HBs or HBsAb test result greater than 10 mIU/mL. Sometimes these test results are under 10 and there is concern whether these low levels will still provide protection against hepatitis B. Anti-HBs or HBsAb test results can decrease over time, but an individual can still be protected even if the test results are less than 10 mIU/mL.

If your test results are low, your doctor may recommend a booster shot or a repeat of the series. If you confirm you completed the vaccine series, you can get a booster dose of the vaccine. Your surface antibody level will be tested again 1 or 2 months after the booster. If the blood test result is greater than 10 mIU/mL, then you are protected and will not require an additional booster shot in the future. If a booster shot does not result in a level greater than 10, then complete the remaining two-doses of the vaccine series and recheck the levels again after 1-2 months. Retain a copy of the anti-HBs titer test as proof of protection.

Hep B Titer Test Required By Most Schools And Employers

This assay is used to determine immune status for Hepatitis B.

Hepatitis B Surface Antibody : The surface antibody is formed in response to the hepatitis B virus. Your body can make this antibody if you have been vaccinated, or if you have recovered from a hepatitis B infection. If this test is positive, then your immune system has successfully developed a protective antibody against the hepatitis B virus. This will provide long-term protection against future hepatitis B infection. Someone who is surface antibody positive is not infected, and cannot pass the virus on to others.

This is a Quantitative test required by many schools and medical programs. Levels of anti-HBs will be provided.

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My Partner Has Been Diagnosed With Hepatitis B Can Transmission Be Prevented By Vaccination

A hepatitis B diagnosis can be scary and confusing for both you and your loved ones, especially if you are unfamiliar with the virus. Hepatitis B is known to be sexually transmitted, and you may wonder how you can continue your relationship with someone who has been infected. The good news is that hepatitis B is vaccine preventable. This means that after you complete the vaccine series, you cannot contract hepatitis B through any modes of transmission you are protected for life!

However, it is important to remember that the vaccine willonly work if a person has not been previously infected. Therefore, it is necessary to take certain steps after your partners diagnosis to protect yourself from becoming infected.

The first step is to visit the doctor and get tested, even if you think that you do not have it. Since hepatitis B often has no symptoms for decades, testing is the only way to know your status. The doctor should perform the Hepatitis B Panel test a simple blood draw that shows hepatitis B surface antigen , hepatitis B surface antibody , and hepatitis B core antibody total . Looking at these three blood test results together will show if you have a current infection, have recovered from a past infection, or if you need to be protected through vaccination. Once you receive your results, this chart can help you understand what they mean.

Preventing Transmission through Vaccines:

Regulatory Recommendations For Clinical Development Of Hbv Immunoglobulins

Patent WO1987000862A1

WHO mentions the use of HBV immunoglobulin in newborn infants whose mothers are HBsAg-positive, in anyone following exposure to the percutaneous or mucous membrane with HBsAg-positive blood or body fluids, following sexual exposure to an HBsAg-positive person, or to protect from recurrent HBV infection following liver transplantation. The HBV immunoglobulins are generally considered as adjuvants to the vaccine. A recent study showed a better response rate in HBV perinatal transmission in the group who received both immunoglobulin and HBV vaccine.

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Safety Of Hbv Vaccines

HBV vaccines are mostly safe. However, absolute contraindication to HBV vaccination is hypersensitivity to yeast or any vaccine constituent. In addition, anaphylaxis, deranged liver enzymes, erythema multiforme, arthritis, multiple sclerosis, Guillain-Barré syndrome, neuritis, thrombocytopenia, optic neuritis, transverse myelitis, and alopecia have been reported. Few reports of arthritic, neurological, gastrointestinal and immunological adverse reactions subsequent to HBV vaccination are available. However, surveillance studies conducted in the USA have demonstrated that there was no association between serious adverse events and HBV vaccination. The Centers for Disease Control and Prevention has ruled out any confirmed evidence that HBV vaccine causes chronic illness, including multiple sclerosis, rheumatoid arthritis, chronic fatigue syndrome, or autoimmune disorders. The Global Advisory Committee on Vaccine Safety has also confirmed that HBV vaccination is very safe.

What Is A Hepatitis B Surface Antibody Titer

The hepatitis B surface antibody test , looks for antibodies that your immune system makes in response to the surface protein of the hepatitis B virus. The hepatitis B surface antibody is also referred to as anti-HBs and should not be confused with HBsAg, which stands for hepatitis B surface antigen.

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What Does The Test Result Mean

The tests for hepatitis B may be ordered individually but are often ordered in some combination, depending on the reason for testing. Results of the tests are typically evaluated together. Sometimes the meaning of one result depends on the result of another test. However, not all tests are performed for all people.

The table below summarizes possible interpretations of some common patterns of results.

Initial Tests
None detected or detected at very low level Chronic infection but low risk of liver damage carrier state

*Note: There are some types of HBV that do not make e-antigen. In areas where these strains of HBV are common , testing for HBeAg is not very useful. In these cases, a negative HbeAg result does not necessarily mean that the person is not infectious it may be that the person is infected with a strain that does not make the e-antigen.

Monitoring treatment of chronic infection: If the results from initial and follow-up testing indicate that a person has chronic hepatitis B, then the individual may be treated with medication and the effectiveness of that treatment may be monitored using the tests for HBe and HBs antigen and antibody and HBV DNA:

Regulatory Recommendations For Clinical Development Of Recombinant Hbv Vaccines

Medical School – Hepatitis B Testing

The WHO guidelines on clinical investigation of HBV immunoglobulins recommends that new or significantly modified recombinant HBV vaccine formulations should have extensive product characterization, immunogenicity testing, safety testing and proof-of-concept studies in animals. Variations in manufacturing, alteration in vaccine formulation or change in the route of administration require immunogenicity studies together with adequate animal safety/toxicological studies., Pre-clinical investigation of HBV vaccines should follow WHO guidelines. As no effects, apart from those on immunity, are expected with sole HBV vaccines, safety pharmacological studies are also not required. Toxicology studies should be performed as per WHO guidelines. Such studies should also reflect the intended clinical use of the vaccine in special populations like neonates and children. The assessment of immune responses should rely on the anti-HBsAg antibody titer in serum, using a validated and standardized assay.

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The Immunological Effect Of Booster Vaccination In Non

To confirm the efficacy of booster HBV vaccination in non-responders and low-responders, we evaluated 33 subjects at 1 year after booster vaccination and 10 subjects at 2 years after booster vaccination. Although the anti-HBs titer increased significantly after booster vaccination, this response was not sustained .

Serial changes in the anti-HB titers of subjects who received a booster vaccination. The vertical axis shows the change in anti-HB titer over time. The horizontal axis shows the indicated time points at which the anti-HB titer was measured at 1 year and 2 years after vaccination. Statistical significance was evaluated using the Friedman test. P values of < 0.05 were considered to indicate statistical significance. n.s.: not significant

What Do The Results Mean

A hepatitis B blood panel consists of three tests that can be done with just one blood sample:

  • Hepatitis B surface antigen . A positive test indicates that youre infected with hepatitis B and that you can spread it to other people. Further tests are needed to see if you have an acute or chronic infection.
  • Hepatitis B core antibody . A positive result can indicate a past or current hepatitis B infection, but doesnt mean youre immune. A positive result needs to be interpreted by a doctor by examining the results of the other two tests.
  • Hepatitis B surface antibody . A positive test indicates that youre protected from hepatitis B either through previous infection or vaccination .

The combination of these tests can indicate your hepatitis B status and whether you need to be vaccinated. Your test will give a negative or positive result for each category depending on whether your results are above or below the cutoff value.

Most peoples test results fall into the following categories. But its possible to have a result that doesnt fall into one of these groups. If youre reading your results yourself, be careful not to confuse HBsAb with HBcAb.


is associated with hepatitis B immunity after vaccination. But research has found that anti-HBs decline over time.

A found that more than 95 percent of people had anti-HBs levels greater than 10IU/L two years after vaccination. But this rate decreased to 70 percent after eight years.

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Hepatitis B Titer Test: Who Needs It Results And Next Steps

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Titer tests measure antibodies in your blood. Antibodies are proteins produced by your immune system in response to foreign substances like viruses, bacteria, or chemicals.

A hepatitis B titer test specifically looks for antibodies that suggest that you’re immune from the hepatitis B virus either from vaccination or previous exposure to the virus.

Keep reading to learn more about hepatitis B titer tests including what they’re used for, what the results mean, and what to expect during the test.

A hepatitis B titer test measures antibodies in your blood to see if you’re immune either due to vaccination or previous infection.

Hepatitis B is a viral infection that targets your liver. It can be transmitted by coming into contact with the bodily fluids of an infected person. A person with the virus can also infect their child during birth.

Hepatitis B can develop into a chronic infection. Chronic infection occurs when your body can’t fight off the virus within six months. Chronic hepatitis B infections most commonly develop in young children less than six years old, especially in infants.

Hepatitis B titer tests can be used to evaluate:

  • whether a high-risk person is immune to hepatitis B
  • whether hepatitis B immunoglobulin is needed after a needle prick
  • whether a person needs a hepatitis B vaccine
  • immunity after vaccination

Centers for Disease Control and Prevention recommends that the following people get screened for hepatitis B infection:

Evaluation Of The Booster Effect

Patent WO2006045004A2

Seventy-two HBsAb-negative children received a single booster vaccination. Titer tests were performed a month after receiving the booster vaccination. At this time, 46 were positive, 23 were weakly positive, and 3 were negative. Only 3 children received a booster vaccination, according to the schedule of 0, 1, and 6 months. All 3 showed positive findings a month after completing the booster schedule.

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How Is It Used

The main uses for hepatitis B virus tests include:

  • To determine whether acute signs and symptoms, such as jaundice, fever and fatigue, are due to hepatitis B infection two tests, hepatitis B surface Ag and hepatitis B core antibody IgM, may be performed as part of an acute viral hepatitis panel along with tests for hepatitis A and hepatitis C to determine which virus may be causing the infection.
  • To diagnose chronic HBV hepatitis
  • To monitor chronic hepatitis B infection and its treatment
  • To detect a previous, resolved hepatitis B infection, in a person who is immune compromised or who has hepatitis C and in whom treatment is planned
  • Some of the secondary reasons to perform testing include: to screen for hepatitis B infection in at-risk populations or in blood donors, to determine if someone is a carrier, to detect a resolved infection, and to determine if immunity has developed due to vaccination.

    Generally, one set of tests is used as an initial panel of tests to detect HBV infection or to determine the cause of acute symptoms while another set of tests may be used after a diagnosis is made to monitor possible progression of the disease, to detect chronic infection, and/or to determine carrier status.

    The following table summarizes the set of tests typically used for initial testing:

    The following table summarizes tests that may be used as follow-up after initial tests detect an HBV infection:

    Spontaneous Decrease In Anti

    To confirm the spontaneous decreases in anti-HB titers, we re-measured anti-HB titers in 247 and 91 subjects who did not receive a booster HBV vaccination at 1 and 2 years after completing the initial vaccination schedule, respectively . Overall, the mean anti-HB titers at 1 and 2 years after vaccination were lower than the mean primary response titers . During the observation period, 18 of the 247 and 17 of the 91 subjects showed anti-HB titers of < 10 mIU/mL at 1 and 2 years after vaccination, respectively.

    Correlation between the primary response and the anti-HB titer at 1 and 2 years after vaccination. The vertical axis shows the anti-HB titers at 1 year and 2 years after vaccination. The horizontal axis shows the primary response to vaccination. Spearmans correlation coefficient was used to assess the correlation between the anti-HB titer and the primary response at both time periods both values were statistically significant: r=0.893, p< 0.0001 r=0.902, p< 0.001.

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    What Do I Do If Im A Hepatitis B Vaccine Non

    Approximately 5-10% of people do not develop protective antibodies following the completion of the hepatitis B vaccine series. This is confirmed with a blood test called an anti-HBs titer test which is given 4 weeks following the completion of the series. If the test shows the titer is less then 10 mIU/mL the general recommendation is to complete the series again using a different brand of vaccine . A person is considered to be a non-responder if they have completed 2 full vaccination series without producing adequate protective antibodies.

    Another vaccine option is the new two-dose hepatitis B vaccine, HEPLISAV-BTM. The new vaccine is expected to increase immunization rates for adults in the United States and is administered over a one-month period. The vaccine provides greater seroprotection, which can mean a greater antibody response especially in adults who may be older, obese or live with type 2 diabetes making it an effective vaccine option.

    It is also possible that a person who does not respond to the vaccine may already be infected with hepatitis B. Therefore, testing for the presence of the hepatitis B virus is recommended before diagnosing a person as a vaccine non-responder.

    CDC Recommendations for Hepatitis B Vaccine Non-Responders

    Check out our previous post on the topic here.


    HEPLISAV-B. Retrieved from:

    What Is Hepatitis D And How Is It Associated With Hepatitis B

    Hepatitis A: CDC Viral Hepatitis Serology Training

    Hepatitis D is another virus that can cause liver infections, but only if hepatitis B is also present. A person may become infected with both viruses at the same time or may first be infected with hepatitis B and then become infected with HDV . In the U.S., the incidence of HDV is low. There is no vaccine for HDV, but since it causes infections only in the presence of HBV, it may be prevented with the HBV vaccine.

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    Sequence Following An Initial Negative Hepatitis B Surface Antibody Titer

    As you obtain documentation, please submit documentation of each step to CastleBranch

    • Initial Hepatitis B titer negative for immunity
    • Receive Hepatitis B challenge dose/booster
    • Repeat Hepatitis B titer 4-6 weeks after challenge/booster vaccine
  • If Repeat Hepatitis B titer is positive for immunity requirement will be marked Complete
  • If Repeat Hepatitis B titer is negative for immunity
  • Receive the remainder of the vaccines in the Hepatitis B vaccine series
  • If challenge dose/booster was Engerix-B or Recombivax HB
  • 2 additional vaccines are needed
  • Receive one as soon as possible after you receive notice that the repeat titer is negative
  • Receive final vaccine 5-6 months after the challenge dose/booster.
  • If challenge dose/booster was Heplisav-B
  • 1 additional vaccine is needed
  • Receive as soon as possible after you receive notice that the repeat titer was negative.
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