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.
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Meningococcal B. Travel Vaccines. Disease Issues. For Adults. Tests and Interpretation. For Healthcare Personnel. Pregnancy, Perinatal, and Infants. For Children and Teens. Vaccine Storage and Handling. What are the signs and symptoms of hepatitis B? Back to top. What are the various serologic tests for hepatitis B? Table 1: Hepatitis B laboratory nomenclature. Hepatitis B surface antigen is a marker of infectivity. Antibody to hepatitis B surface antigen is a marker of immunity.
Antibody to hepatitis B core antigen is a nonspecific marker of acute, chronic, or resolved HBV infection. IgM anti-HBc:.
IgM antibody subclass of anti-HBc. Antibody to hepatitis B "e" antigen may be present in an infected or immune person. HBV Deoxyribonucleic acid is a measure of viral load and reflects viral replication. Table 2. Postvaccination testing, when it is recommended, should be performed months after the last dose of vaccine. May be distantly immune, but the test may not be sensitive enough to detect a very low level of anti-HBs in serum. May be susceptible with a false positive anti-HBc.
May be chronically infected and have an undetectable level of HBsAg present in the serum. Who should be tested for anti-HBs after vaccination? Testing for anti-HBs after vaccination is recommended for the following groups whose subsequent clinical management depends on knowledge of their immune status:.
Infants born to HBsAg-positive women and infants born to women whose HBsAg status remains unknown for example, infants surrendered shortly after birth ; postvaccination serologic testing should consist of testing for anti-HBs and HBsAg.
Healthcare professionals and public safety workers at risk for blood or body fluid exposure. Hemodialysis patients and other persons who might require outpatient hemodialysis , HIV-infected persons, and other immunocompromised persons such as hematopoietic stem-cell transplant recipients or persons receiving chemotherapy , to determine the need for revaccination and the type of follow-up testing, and.
Sex partners of HBsAg-positive persons, to determine if they have not achieved immunity and will need revaccination and to continue to use other methods of protection against HBV infection. Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission.
While test results are pending, all infants with birth weights of 2, grams or more born to women without documentation of HBsAg test results should receive the first dose of single-antigen HepB without HBIG within 12 hours of birth.
If the mother is determined to be HBsAg positive, her infant should receive HBIG as soon as possible but no later than age 7 days, and the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers. If the mother is determined to be HBsAg negative, the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-negative mothers.
For preterm infants weighing less than 2, grams at birth:. If maternal HBsAg status is positive:. Give 3 additional HepB doses for a total of 4 doses at ages 1, 2 to 3, and 6 months, or HepB-containing combination vaccine Pediarix at ages 2, 4, and 6 months. If maternal HBsAg status is unknown:. Three additional doses of vaccine for a total of 4 doses should be administered according to the recommended schedule on the basis of the mother's HBsAg test result.
If it is not possible to determine the mother's HBsAg status:. The vaccine series should be completed according to a recommended schedule for infants born to HBsAg positive mothers. If the maternal HBsAg status is negative:. If you are certain that appropriate maternal testing was done and a copy of the mother's original laboratory report indicating that she was HBsAg negative during this pregnancy is placed on the infant's chart, delay the first dose of HepB vaccine until age 1 month or hospital discharge even if weight is still less than 2, grams , whichever comes first.
Should all children age 0 through 18 years be vaccinated against hepatitis B? Which hepatitis B vaccines can be given to adult patients? The following groups are recommended for hepatitis B vaccination:.
Sex partners of HBsAg-positive people. Sexually active people who are not in long-term, mutually monogamous relationships. People seeking evaluation or treatment for a sexually-transmitted infection. Men who have sex with men. Current or recent injection drug users. Household contacts of HBsAg-positive people. Residents and staff of facilities for developmentally disabled people. Healthcare and public safety workers with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids.
People with end-stage renal disease, including predialysis, hemo-, peritoneal-, and home-dialysis patients. International travelers to regions with intermediate or high levels of HBV infection; visit wwwnc. People with chronic liver disease, including, but not limited to, persons with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase ALT or aspartate aminotransferase AST level greater than twice the upper limit of normal.
People with hepatitis C virus infection. People with HIV infection. Unvaccinated adults with diabetes mellitus from 19 through 59 years of age. Unvaccinated adults with diabetes mellitus who are age 60 or older at the clinician's discretion. All other people who wish to be protected from HBV infection. Acknowledgement of a specific risk factor is NOT a requirement for vaccination. If Twinrix is not available or if you choose not to use Twinrix to complete the hepatitis A vaccine HepA and HepB series, you should do the following:.
The persistence of anti-HBs over time is correlated with the peak level of anti-HBs immediately achieved after primary immunization [ 9 ]. In other words, the higher the vaccine-induced anti-HBs concentration after the primary vaccination course, the longer the antibodies will persist. The issue of duration of protection can be addressed, as documented in by Bruce et al [ 10 ] in this issue of The Journal of Infectious Diseases , by long-term follow-up studies of immunized cohorts who continue to be exposed to HBV and by exploring anamnestic responses to HBsAg through challenge.
Bruce et al [ 10 ] present for the first time results of a year follow-up study and response to a booster dose in an Alaskan Native population. It is the longest cohort study on extended protection after hepatitis B vaccination to date. Initial anti-HBs level and age at vaccination seemed to play an important role in the persistence of antibodies. These results are similar to findings of other cohort studies in other parts of the world carried out through 20—25 years of follow-up [ 11—16 ].
Indeed, in immunocompetent individuals, the specific immunity to HBsAg outlasts the presence of vaccine-induced antibodies, conferring effective long-term protection against acute disease and development of HBsAg carriage, even in those showing waning or disappearing anti-HBs [ 17—18 ].
Thus, a negative anti-HBs result does not necessarily indicate lack of immunity in vaccinated persons; it is immune memory that matters [ 8 ]. The mechanism for continued vaccine-induced protection is thought to be preservation of immune memory through selective expansion and differentiation of clones of antigen-specific B and T lymphocytes [ 19 ].
There is, however, recent evidence suggesting that the immune memory may begin to wane after the second decade of vaccination, but this does not seem to imply increased susceptibility to clinically significant HBV disease. Absence of an anamnestic response after such challenge vaccination may not necessarily mean that individuals are susceptible to HBV infection, but further research is needed in this field.
Some long-term follow-up studies have documented breakthrough HBV infections, illustrated by seroconversion to anti-HBc but, in this recent Alaskan study [ 10 ], virtually no clinical significant infections acute diseases or carriage were reported [ 8 ]. From a public health point of view, prevention of viral carriage remains of utmost importance; the hepatitis B vaccination program in Alaska is among the earliest and shows excellent efficacy in reducing rates of chronic HBV infection and hepatocellular carcinoma [ 20 ].
Immunity against HBV provides protection against infection as well as against disease. Protection against infection is associated with presence of antibody, which is directly related to the peak concentration of anti-HBs after primary vaccination. Protection against disease is associated with immune memory, which persists beyond the time when anti-HBs disappears. The question that is nearly as old as hepatitis B vaccine itself—how long will immune memory last?
The data presented by Bruce et al confirm statements from the World Health Organization, Centers for Disease Control and Prevention, and Viral Hepatitis Prevention Board that booster vaccination against hepatitis B for immunocompetent children and adults is not recommended [ 22—24 ].
The absence of anamnestic response requires further understanding, and long-term follow-up studies are still needed to show how long immune memory persists and whether, when and at what age booster doses may be needed to guarantee continued protection.
Financial support. Potential conflict of interest. Author certifies no potential conflicts of interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between and Lancet ; : — Google Scholar. Global epidemiology of hepatocellular carcinoma: an emphasis on demographic and regional variability. Clin Liver Dis ; 19 : — Genome-wide characterization of hepatitis B mutations involved in clinical outcome.
Heredity ; 97 : — The influence of age on the development of the hepatitis B carrier state. Proc Biol Sci ; : — World Health Organization. Immunization coverage. Fact sheet No. Updated September Accessed 15 September Chen DS. Hepatitis B vaccination: the key towards elimination and eradication of hepatitis B. J Hepatol ; 50 : — Both older participants and those who were older when they were vaccinated were more likely to lack protective antibody.
The authors find these results encouraging, both for the durability of protective antibody titers in most of the healthcare workers studied and for the brisk anamnestic response induced by booster doses in the others, even decades after original vaccination. In these individuals, exposure to actual virus would be expected to act as a de facto booster, eliciting protective antibody titers before viral infection could be established.
Thus, these data support current guidelines that HBV boosters are unnecessary in healthy vaccinated healthcare workers. Boosters are recommended for patients who are on dialysis or otherwise immunocompromised and who have documented suboptimal antibody levels.
Gara N et al. Durability of antibody response against hepatitis B virus in healthcare workers vaccinated as adults. Clin Infect Dis Feb 15; Clin Infect Dis Feb 15 For healthy healthcare workers, boosters don't seem necessary.
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