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Hepatitis B

 Serology/Boosters

If an individual received the hepatitis B immunizations in 1984, was that vaccine different than is given now? And does the individual need to be revaccinated?

A person vaccinated in 1984 would have gotten the plasma-derived hepatitis B vaccine (the recombinant vaccine was licensed in 1986). The plasma-derived vaccine was effective, and anyone who got a complete series does not need to be revaccinated using the newer vaccine. (6/26/03)
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If I am exposed to hepatitis B, and have not received the series of immunizations, would I receive any protection from that exposure by starting the series at that time? In other words, is it to late to start the series after the exposure?

Guidelines for hepatitis B post-exposure prophylaxis are included in the ACIP recommendations for healthcare workers, ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf, (see page 23), and in hepatitis B chapter of the Pink Book, http://www.cdc.gov/nip/publications/pink/hepb.pdf. The vaccine is part of the recommended prevention treatment following an exposure along with HBIG, which provides temporary antibody protection until the person’s immune system can develop antibodies in response to the vaccine series. If you were not infected by the exposure, the vaccine will offer protection from possible future exposures. If you were infected, the vaccine will not harm you, but would be of no benefit. (6/26/03)
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Would a dose of 1 ml of 10 mcg Engerix B (2 vials of the Pediatric dose) be the same as 1 ml of 20 mcg (1 vial of the Adult dose)?

The pediatric formulation of Engerix-B is not licensed by FDA for use in adults. Adults 20 years of age and older should receive 1 mL (20 mcg) of the adult formulation of Engerix-B. With Recombivax HB, two pediatric doses can be used in place of an adult dose, because Recombivax is licensed for that usage. (6/26/03)
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Would you clarify the age groups for the various hepatitis B vaccine formulations?

Recombivax (Merck) is approved by FDA such that either vaccine (pediatric or adult) can be used for people of any age. For the routine 3-dose schedule, persons <20 should receive 0.5 ml per dose, and those 20 and older should receive 1.0 ml per dose. The 2-dose "adolescent" schedule for children 11-15 years of age is two 1.0 ml dose separated by at least 4 weeks.

Engerix-B (GSK) is NOT approved for this use. Pediatric vaccine can be used through age 19. The pediatric formulation is not approved for use in persons 20 years and older.

Twinrix is licensed for use in persons 18 years of age and older. (6/26/03)
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What do I do if a worker wants the hepatitis B series but can’t remember if they have already had the vaccine, or they can’t remember how many doses they got?

The safest option when there is no documentation is to vaccinate. You could test to ascertain if the person has a protective level of antibodies (anti-HBs = >10 mIU/Ml). (6/26/03)
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Is it true that the hepatitis B virus can live for months on a surface and infect someone if they have a cut or break in the skin.

The hepatitis B virus is a hardy virus and probably lives on surface for several weeks, but not months. Infection from contact with a surface is not likely, because the material dries and doesn’t penetrate through the skin. It is theoretically possible, but in reality probably very rare. (6/26/03)

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Schedule

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If an infant receives the second Hepatitis B dose 24 days after the first dose and the third dose is administered 3 or 4 days before the child is 6 months of age, would this be considered a valid series?

Yes, but just barely. In this case the child has had the interval between the first and second doses reduced by the 4-day grace period. The minimum age for the third dose of Hepatitis B vaccine, which is 6 months, has also been reduced by the 4-day grace period.

This sort of immunization practice is not ideal. The grace period is a last resort, not something that one uses for scheduling. By ACIP’s definition, these doses would both be valid because they fall within the 4 days recommended by ACIP. But that does not mean a state will accept them as valid. Some states do not accept the 4-day grace period for any dose of any vaccine because of complexities of day care and school laws. Any time you are giving vaccines that close to the bare minimum, you really need to rethink how to give vaccines according to the actual recommended schedule. ACIP General Recommendations (see page 3). (2/13/03)
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Would you clarify the hepatitis B vaccine minimum intervals?

The hepatitis B minimum intervals are as follows:
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Dose 2 should be separated from dose 1 by at least one month (4 weeks or 28 days).
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Dose 3 should be separated from dose 2 by at least 2 months (8 weeks) AND from dose 1 by at least 4 months (16 weeks).

You may use weeks (1 month = 4 weeks) to calculate intervals up to 4 months. Beyond 4 months, you should use calendar months. (6/26/03)
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I work at a residential facility for children. Many of the kids who come into my care are behind on their vaccines, especially the Hepatitis B series. Many of these kids are sexually active. Can I routinely follow the catch-up schedule for them? Sometimes they are here for less than six months.

Yes, you can follow the schedule using the minimum intervals. You must have at least 4 weeks (28 days) between doses one and two, at least 2 months (8 weeks) between doses two and three, and at least 4 months (16 weeks) between doses one and three. That’s as close together as you can give the doses. ACIP General Recommendations (see page 3) (2/13/03)
* If I received the first two shots in the hepatitis B series, but did not receive the third, and it is now 10 years later, should I go ahead now and get the last one?

Regardless of when you started the hepatitis B series, you should just pick up where you left off and complete the series. It is not necessary to add doses or restart the series if the interval between doses is longer than recommended. (6/26/03)

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Serology/Boosters

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If inactivated fractional vaccines, specifically Td, require booster doses every ten years, why are routine hepatitis B booster doses not recommended?

Available data show that vaccine-induced hepatitis B antibody levels do decline with time. Nevertheless, immune memory remains intact for at least 15 years following immunization, and both adults and children with declining antibody levels are still protected against significant hepatitis B virus (HBV) infection (e.g., clinical disease, HBsAg antigenemia, or significant elevation of liver enzymes). Exposure to HBV results in an anamnestic anti-HBs response that prevents clinically significant HBV infection. Chronic HBV infection has only rarely been documented among vaccine responders.

For adults and children with normal immune status, booster doses of vaccine are not recommended nor is routine serologic testing to assess immune status. The need for booster doses after longer intervals will continue to be assessed as additional information becomes available. Pink Book Chapter: Hepatitis B (2/13/03)
* What is your recommendation if a person who is tested for Hep B antibodies following completion of vaccination is found to be nonreactive to the Hep B antibodies? Also, what if a person has a blood exposure and is found to be nonreactive to Hep B antibodies even though they have completed the vaccination for hep B and may have had a earlier reactive antibody result to Hep B antibodies. And what if someone has not had a previous reactive antibody test done after completion of vaccination?

The key to the first question is how long after the hepatitis B series the testing is done. As the question is worded, it appears to be about testing done immediately after vaccination (1-2 months). In this case, the answer is that this person should get another 3-dose vaccine series and be tested again after the third dose. (NOTE: If the person has already had two complete hepatitis B vaccine series, additional doses are not recommended. The person should be considered a non-responder.)

A person whose immune status is in doubt, who has a percutaneous or permucosal exposure to blood known to be infected with hepatitis B virus, should get one dose of HBIG and a booster dose of hepatitis B vaccine. (For more details see CDC guidelines at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm, Table 3.)

Routine post-vaccination antibody testing is not recommended, except for certain groups (e.g., people at high risk of blood exposures) and only if it is done within 2 months of vaccination. Otherwise the result could be negative, even if the person responded to the vaccine. (6/26/03)
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If a new healthcare worker with a documented history of three doses of hepatitis B vaccine did not have a serology test done, should we test them when they start employment or do we wait until they have an exposure.

In 1997, ACIP and the Hospital Infection Control Practices Advisory Committee (HICPAC) published comprehensive recommendations for the immunization of healthcare workers, ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf. One of the recommendations was that healthcare workers who have contact with patients or blood and are at ongoing risk for injuries with sharp instruments or needlesticks should be routinely tested for antibody after vaccination. However, a catch-up program of serologic testing for healthcare providers vaccinated prior to December 1997 is not recommended. These individuals should be tested if they have a significant exposure to HBV.

For employees in this situation who want to be sure of their immune status, you could test them now. But be aware that if they have no antibody, it could mean either that they failed to respond to the vaccine series or that they responded and their antibody level has fallen. We know this occurs in about 50% of people within 5 to 6 years after vaccination.

What we have recommended for situations in which no antibody is detected is to give the person one dose of vaccine and test again one month later. If the person responded to the original series, this dose will stimulate the immune system to boost their antibody and the test will be positive. Then simply document the response; no additional doses of vaccine or further testing are needed.

If the person does NOT respond to this booster dose, we suggest you complete a second series with two more doses of vaccine and retest 4-6 weeks after the last dose. If there is a positive response, document it and no further testing or vaccine doses are needed. If the person does not respond after a second three-dose series, considered him or her a non-responder and counsel accordingly. At this point, if you have not already done so, you should test for surface antigen (HBsAg). It is possible that they are not responding to the vaccine because they are infected with the hepatitis B virus.

Routine postvaccination testing is not recommended for persons at low risk of exposure, such as public safety workers and healthcare workers without direct patient contact. (6/26/03)
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If an employee at our health services facility sustains a blood exposure and has documented evidence of a positive hepatitis B surface antibody (anti-HBs) response, do they require a booster?

No, a booster dose is not necessary. Please refer to Table 3, “Recommended postexposure prophylaxis for percutaneous or permucosal exposure to hepatitis B virus, United States” in the 1997 ACIP recommendations for “Immunization of Health-Care Workers”, ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf. (6/26/03)
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If our health-care workers have a documented positive antibody response (anti-HBs) in the past, do we need to test them if they sustain a blood exposure.

No, not if you have a documented positive antibody response (>10 mIU/mL) following the 3-dose hepatitis B vaccine series, ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf (Table 3, page 23). (6/26/03)
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What is the recommendation for a healthcare worker who has been tested for hepatitis B antibodies after three doses of vaccine and the lab test shows no antibodies?

Persons who do not respond to the first series of hepatitis B vaccine should complete a second three-dose vaccine series. The second vaccine series should be given on the usual 0, 1, 6-month schedule. A 0, 1, 4-month accelerated schedule may also be used. Revaccinated healthcare workers and others for whom postvaccination serologic testing is recommended should be retested at the completion of the second vaccine series.

Fewer than 5% of persons receiving 6 doses of hepatitis B vaccine administered by the appropriate schedule in the deltoid muscle fail to develop detectable anti-HBs antibody. Some persons who are anti-HBs negative following 6 doses may have a low level of antibody that is not detected by routine serologic testing. One reason for persistent nonresponse to hepatitis B vaccine is that the person is chronically infected with HBV. Persons who fail to develop detectable anti-HBs after 6 doses should be tested for HBsAg. Persons who are found to be HBsAg-positive should be counseled accordingly. Vaccine non-responders who are HBsAg-negative should be considered susceptible to HBV infection and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to HBsAg-positive blood, ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf (see page 23). (6/26/03)
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We give HIV patients a 4-dose series of hepatitis B vaccine (40 mcg) at 0, 1, 2, and 6 months. If they are anti-HBs negative after the 4th dose, we give a 40 mcg booster at 12 months. If they remain negative after this dose, what should we do?

The best explanation for vaccination of hemodialysis patients and other immunocompromised high-risk patients (e.g., HIV ) is in the CDC “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”, http://www.cdc.gov/mmwr/PDF/rr/rr5005.pdf
 (see pages 25-26).

The primary schedule for the 40 mcg formulation of Engerix-B is four doses at 0, 1, 2, and 6 months. (Recombivax-B uses a three-dose schedule at 0, 1, and 6 months.) Vaccinees should be tested for anti-HBs 1-2 months after the last primary dose to determine their response to the vaccine (adequate = >10 mIU/mL). If the response to the primary series is inadequate, then the patient should be revaccinated with three additional doses (regardless of which vaccine is used) and retested for response. No additional doses of vaccine are warranted for those who do not respond to the second series. (6/26/03)
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Is hepatitis B surface antigen (HBsAg) detectable in the serum after vaccination with the hepatitis B vaccine?

A false positive reading for hepatitis B surface antigen can persist for 3-4 weeks after a dose of hepatitis B vaccine. (6/26/03)

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