It has been reported that a patient can have antibody to one surface antigen type and be acutely infected with a virus of a different subtype, which means the individual may have coexisting HBsAg and anti-HBs. Tests on individuals who have received blood transfusions or hemophiliacs receiving plasma components may result in false-positives for antibody to hepatitis B surface antigen.
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It is worth noting that pregnancy is not a contraindication to HepB vaccination, and that women with gestational diabetes are more likely to develop type-1 or type-2 diabetes later in life. Diabetic women who become pregnant can be vaccinated, if indicated. At what anatomic site should hepatitis B vaccine be administered to adults? What needle size should be used?
The deltoid muscle is recommended for routine intramuscular IM vaccination among adults. The anterolateral thigh also can be used. The gluteus muscle should not be used as a site for administering HepB. Is post-vaccination testing needed for adults who receive hepatitis B vaccine? Serologic testing for immunity after HepB vaccination is recommended only for people whose subsequent clinical management depends on knowledge of their immune status. Testing is not necessary after routine vaccination of adults.
Post-vaccination anti-HBs testing is recommended for the following: healthcare and public safety workers at a reasonable risk of continued exposure to blood on the job; immune compromised people; and sex or needle-sharing partners of HBsAg-positive people.
Testing should be performed 1 to 2 months after the last dose of vaccine. Sexually transmitted infections, including hepatitis B, can be transmitted by sexual assault. Unless the victim has a documented history of completed HepB vaccination, a series of HepB alone 2 or 3 doses depending on brand should be administered with the first dose as soon as possible after the assault.
If a patient receives HepB vaccine while undergoing hemodialysis, will the vaccine be effective? Will the dose need to be repeated? Recommendations for immune compromised people, such as hemodialysis patients, are different than those for immune-competent people. Hemodialysis patients who do not respond to an initial vaccine series should be revaccinated with two to four additional doses of HepB depending on the brand. For hemodialysis patients who have responded with adequate anti-HBs postvaccination testing should be done 1 to 2 months after the vaccine series to HepB vaccination, no HBsAg testing is needed but anti-HBs should be done annually.
Retesting immediately after the booster dose is not necessary. What is the maximum number of hepatitis B vaccine doses a dialysis patient can receive? There is no maximum number of HepB booster doses a dialysis patient can receive. Serology is not recommended more frequently than once a year, so boosters wouldn't be given more than once a year.
A physician ordered a mcg dose of hepatitis B vaccine for a hemodialysis patient. The clinic does not stock the Recombivax HB mcg dose dialysis formulation Merck and would like to give 2 doses of Engerix-B mcg dose GSK for each dose in the series.
If given on the same day as separate injections in separate sites, two injections of Engerix-B 20 mcg can be counted as the equivalent of one Recombivax HB mcg dose. According to the package insert, Engerix-B is licensed for use in this manner vaccine package inserts for all vaccines are available at www. Note that an all-Engerix-B or mixed-brand dialysis schedule is a 4-dose series doses at 0, 1, 2, and 6 months. Vaccination using only Recombivax HB dialysis formulation is a 3-dose schedule doses at 0, 1, and 6 months.
Vaccination of a hemodialysis patient also may be completed with Heplisav-B using the standard 0. Is this practice advisable? When using Engerix-B or Recombivax HB brands of HepB to vaccinate hemodialysis or other immunocompromised people, a higher dose is recommended, so to the extent these patients are immunocompromised, this is within ACIP recommendations note that "immunocompromised" is not defined in the recommendations.
Regardless, this practice is appropriate for several reasons, including that these patients may be starting hemodialysis soon, and because use of the higher dose is not harmful. When using Heplisav-B, the standard 0. Can a dialysis or pre-dialysis patient receive Heplisav-B vaccine? Use the standard dose and dosing interval 1 month. I would like more information about Twinrix, the combination hepatitis A and B vaccine.
The vaccine contains EL. In the United States, Twinrix is licensed for use in people who are age 18 years or older. It can be administered to people who are at risk for both hepatitis A and hepatitis B, such as certain international travelers, people with chronic liver disease, men who have sex with men, illegal drug users, or to people who want to be immune to both diseases.
A standard Twinrix series consists of 3 doses given intramuscularly on a 0, 1, and 6 month schedule. It consists of 3 doses given within 3 weeks, followed by a booster dose at 12 months 0, 7 days, 21 to 30 days, and 12 months. The 4-dose schedule could benefit individuals needing rapid protection from hepatitis A and hepatitis B, such as some people traveling imminently. Twinrix cannot be used for post-exposure prophylaxis.
I have seen adults who have had 1 or 2 doses of Twinrix, but we only carry single-antigen vaccine in our practice.
How should we complete their vaccination series with single-antigen vaccines? Twinrix is licensed as a 3-dose series for people age 18 years and older. So a dose of Twinrix can be substituted for any dose of the HepB series but not for any dose of the HepA series.
What are the minimum intervals for giving the 3-dose series of Twinrix? Minimum intervals for Twinrix are 4 weeks between dose 1 and dose 2, and 5 months between dose 2 and dose 3. For Healthcare Personnel Back to top Which people who work in healthcare settings need hepatitis B vaccine?
This requirement does not include personnel who would not be expected to have occupational risk for example, general office workers. Employers must ensure that workers who decline HepB vaccination sign a declination form.
For a fact sheet about this OSHA requirement, go to: www. For adults, administer HepB intramuscularly IM in the deltoid muscle. The gluteus muscle should not be used as a sit for administering HepB. For optimal protection, it is crucial that the vaccine be administered IM, not subcutaneously. Can Heplisav-B be used for vaccinating healthcare professionals?
Heplisav-B is approved as a 2-dose schedule for persons age 18 years and older, including healthcare professionals. The doses should be separated by at least 4 weeks. However, data are limited on the safety and immunogenicity effects when Heplisav-B is interchanged with HepB from other manufacturers. The 2-dose HepB series only applies when both doses in the series consist of Heplisav-B. However, any series containing 2 doses of Heplisav-B administered at least 4 weeks apart is valid, even if the patient received a single earlier dose from another manufacturer.
I work in occupational health and have some patients who are off schedule for their 3-dose hepatitis B vaccine series. They came back for dose 2 in 4 to 6 months rather than getting it 1 month later. In this situation, what is the correct timing for dose 3?
And how long must the interval be between doses before I am required to restart the series? The minimal intervals for the 3-dose HepB vaccines are at least 4 weeks between doses 1 and 2, at least 8 weeks between doses 2 and 3, and at least 16 weeks between doses 1 and 3.
Since in your cases 16 weeks or more have elapsed since dose 1, you should schedule dose 3 to be given 8 weeks after dose 2. It is not necessary to restart the series because of an extended interval between doses, no matter how long. Is it safe for a healthcare professional to be vaccinated during pregnancy? Many years of experience with HepB vaccines indicate no apparent risk for adverse events to a developing fetus.
If not vaccinated, a pregnant woman may contract an HBV infection during pregnancy, which might result in severe disease for the newborn. Women who breastfeed their babies and are healthcare professionals can and should be vaccinated against hepatitis B if they haven't been previously vaccinated. Receipt of the vaccine is not a reason to discontinue breastfeeding. There are no clinical studies of Heplisav-B in pregnant women.
Available human data on Heplisav-B administered to pregnant women are insufficient to assess vaccine-associated risks in pregnancy. Until safety data are available for Heplisav-B, providers should continue to vaccinate pregnant women needing HepB vaccination with a vaccine from a different manufacturer.
Which HCP need serologic testing after receiving a hepatitis B vaccine series? All HCP, including trainees, who have a high risk of occupational percutaneous or mucosal exposure to blood or body fluids for example, HCP with direct patient contact, HCP at risk of needlestick or sharps injury, laboratory workers who draw, test or handle blood specimens should have postvaccination testing for antibody to hepatitis B surface antigen anti-HBs. Postvaccination testing for persons at low risk for mucosal or percutaneous exposure to blood or body fluids for example, public safety workers and HCP without direct patient contact likely is not cost-effective; however, those who do not undergo postvaccination testing should be counseled to seek immediate testing if exposed.
There are two options for healthcare personnel who test negative after completing their first HepB series. The first option is to give one dose of HepB, then retest for anti-HBs.
If the result is positive, the person should be considered immune. If negative, the person should receive the remaining doses in the series, and then retest for anti-HBs. Those found to be HBsAg negative but total anti-HBc positive were infected in the past and require no vaccination or treatment.
If the HBsAg and total anti-HBc tests are positive, the person should receive appropriate counseling for preventing transmission to others as well as referral for ongoing care to a specialist experienced in the medical management of chronic HBV infection. They should not be excluded from work.
Heplisav-B may be used for revaccination following an initial HepB series that consisted of doses of Heplisav-B or doses from a different manufacturer. If the test is still negative after a second vaccine series, the person should be tested for HBsAg and total anti-HBc to determine their HBV infection status.
The choice of option 1 and option 2 should be based on epidemiologic considerations and likelihood that the patient is HBsAg positive, since there is a delay in option 1 in determining HBsAg status.
How often should I test HCP after they've received the hepatitis B vaccine series to make sure they're protected? For immunocompetent HCP, periodic testing or periodic boosting is not needed. This information should be made available to the employee and recorded in the employee's health record.
Immunocompetent people known to have responded to HepB vaccination in the past do not require additional passive or active immunization. In this scenario, the initial postvaccination testing showed that the healthcare professional was protected. Only immunocompromised people for example, dialysis patients, some people living with HIV need to have anti-HBs testing performed periodically.
HBIG dosage is 0. In general, no, but the type of testing pre-exposure or post-exposure depends on the healthcare worker's profession and work setting.
The risk might be low enough in certain settings that assessment of hepatitis B surface antibody anti-HBs status and appropriate follow-up can be done at the time of exposure to potentially infectious blood or body fluids. This approach relies on HCP recognizing and reporting blood and body fluid exposures and might be applied on the basis of documented low risk, implementation, and cost considerations.
Trainees, some occupations such as those with frequent exposure to sharp instruments and blood , and HCP practicing in certain populations are at greater risk of exposure to blood or body fluid exposure from an HBsAg-positive patient. We have a new employee with documentation of having received a series of hepatitis B vaccine as an adolescent.
He now tests negative for hepatitis B surface antibody anti-HBs. How should we manage him? Those who test positive following the "booster" dose are immune and require no further vaccination or testing. The "booster" dose counts as the first dose in this series. For more information see www.
If an employee receives both HBIG and hepatitis B vaccine after a needlestick from a patient who is HBsAg positive, how long should one wait to check the employee's response to the vaccine?
At our facility we do routine pre-employment anti-HBs testing regardless of whether the employee has documentation of a hepatitis B vaccination series and consider those who are anti-HBs positive to be immune.
Is this the recommended strategy? Persons who cannot provide written documentation of a complete HepB vaccination series should complete the series, then be tested for anti-HBs 1 to 2 months after the final dose.
Is there a recommendation for a routine booster dose of hepatitis B vaccine? Immunocompetent persons have long-term protection against HBV and do not need further testing or vaccine doses. Some immunodeficient persons including those on hemodialysis may need periodic booster doses of hepatitis B vaccine.
Does CDC recommend restarting the hepatitis B vaccine series in the event the series is interrupted? The series should not be restarted. Continue the series from where you left off. Several physicians in our group have no documentation showing they received hepatitis B vaccine. They are relatively sure, however, that they received the doses many years ago. What do we do now? There is no harm in receiving extra doses of vaccine. Postvaccination anti-HBs testing results should also be documented, including the date testing was performed.
All healthcare settings should develop policies or guidelines to assure valid hepatitis B immunization. An employee thinks she had 3 doses of hepatitis B vaccine in the past but has no documentation of receiving those doses. With this lab result, can't we assume she is immune? A positive anti-HBs indicates that the vaccinated person is immune at the time the person was tested but does not assure that the person has long-term immunity.
An adequate anti-HBs result from a documented vaccine series would assure not only seroprotection, but long-term protection. What should I do now? Do nothing.
Data show that vaccine-induced anti-HBs levels might decline over time; however, immune memory anamnestic anti-HBs response remains intact following immunization. Does the employer have a responsibility in this area beyond providing vaccine? There are no regulations that require removal from job situations where exposure to bloodborne pathogens could occur; this is an individual policy decision within the organization.
OSHA regulations require that employees in jobs where there is a reasonable risk of exposure to blood be offered hepatitis B vaccine.
In addition, the regulation states that adequate personal protective equipment be provided and that standard precautions be followed. Check your state OSHA regulations regarding additional requirements. Adequate documentation should be placed in the employee record regarding non-response to vaccination. If the HBsAg and total anti-HBc tests are positive, HCP should receive appropriate counseling for preventing transmission to others as well as referral for ongoing care to a specialist experienced in the medical management of chronic HBV infection.
Persons who are HBsAg-positive and who perform exposure-prone procedures should seek counsel from a review panel comprised of experts with a balanced perspective for example, infectious disease specialists and their personal physician[s] regarding the procedures that they can perform safely. Can a person with chronic HBV infection work in a healthcare setting? HCP should not be discriminated against because of their hepatitis B status. This document is available at www.
Vaccine Safety Back to top Is hepatitis B vaccine safe? Hepatitis B vaccines have been demonstrated to be safe when administered to infants, children, adolescents, and adults. Since , more than million people, including infants, children, and adults living in the United States have received at least one dose of hepatitis B vaccine; more than a billion doses of hepatitis B vaccine have been given worldwide.
Vaccination causes a sore arm occasionally, but serious reactions are very rare. Is it safe to give hepatitis B vaccine to a pregnant woman? Many years of experience with HepB vaccines indicates no apparent risk for adverse events to a developing fetus. Current vaccines contain noninfectious HBsAg and pose no risk to the fetus. If the mother is being vaccinated because she is at risk for HBV infection for example, a healthcare worker, a person with a sexually transmitted disease, an injection drug user, a person with multiple sex partners, or a person with diabetes who is 19 through 59 years of age , vaccination should be initiated as soon as her risk factor is identified during the pregnancy.
HBV infection affecting a pregnant woman might result in severe disease for the mother and chronic infection for the newborn. Until safety data are available for Heplisav-B, providers should continue to vaccinate pregnant women needing hepatitis B vaccination with a vaccine from a different manufacturer. Does a birth dose of vaccine increase the risk of elevated temperature and subsequent microbiologic evaluations? Administration of HepB soon after birth has not been associated with an increased rate of elevated temperatures or subsequent evaluations for possible sepsis in the first 21 days of life.
Contraindications and Precautions Back to top Who should not receive hepatitis B vaccine? A serious allergic reaction to a prior dose of hepatitis B vaccine or a vaccine component is a contraindication to further doses of HepB vaccine. The recombinant vaccines that are licensed for use in the United States are synthesized in yeast cells into which a plasmid containing the gene for HBsAg has been inserted. Purified HBsAg is obtained by lysing the yeast cells and separating HBsAg from the yeast components by biochemical and biophysical techniques.
People with a severe allergic to yeast should not be vaccinated with vaccines produced in yeast cells. As with other vaccines, vaccination of people with moderate or severe acute illness, with or without fever, should be deferred until the illness improves. Vaccine Storage and Handling How should hepatitis B vaccine be stored? The vaccines must not be frozen. Any vaccine exposed to freezing temperature should not be used.
Do not use these or any other vaccines after the expiration date shown on the packaging. Any vaccine administered after its expiration date should be repeated. Back to top This page was updated on August 30, Hepatitis B infections are more commonly transmitted by blood and other body fluids during sexual activity, intravenous drug use IVDA and inadvertent infected blood or fluid exposure while working in a healthcare environment.
Rarely, one can get hepatitis B from getting a tattoo or acupuncture from a contaminated needle and also dialysis for kidney failure. If one is exposed to and gets a Hepatitis B infection, symptoms can range from nothing to flu-like symptoms like fatigue and headache. Additionally, hepatitis B can result in stomach pain, jaundice yellow skin from liver abnormalities, and nausea and vomiting which lasts for days.
In some cases, symptoms won't begin until six months after the initial exposure. Because so many people have received the Hepatitis B vaccine as part of their routine vaccines, checking the Hepatitis B titer has become common practice to assess one's immunity to hepatitis B.
This hepatitis B vaccine titer is practically used to demonstrate immunity to hepatitis B in people who will be working or studying in healthcare organizations or schools. When ordered in this capacity, the hep b titer is frequently ordered with the MMR titer and varicella titer , all of which are included in the immunization titer panel.
Additionally, some people also need to present a negative TB blood test when going through the clearance process for a new school or job. Sometimes, the Hep B surface antibody test is ordered for other reasons. For example, people sometimes get the blood test to check for immunity when engaging in activities that might lead to an inadvertent exposure to Hepatitis B e. Getting a hepatitis B titer near you is not difficult if there is a Quest Diagnostics' lab near you.
This blood titer test requires fairly standard lab equipment which every lab has available. Who should receive postvaccination testing? When should postvaccination testing be done in infants born to HBsAg-positive mothers? Can anti-HBs levels following vaccination decline over time? Are booster doses of hepatitis B vaccine recommended?
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