Hepatitis B
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Hepatitis B virus
hepatitis b

Hepatitis B is a serious liver disease caused by the hepatitis B virus (HBV). The Centers for Disease Control and Prevention (CDC) estimate that 78,000 new HBV infections occur each year. HBV is spread through contact with the blood or other body fluids of an infected person. HBV can be spread to others one to two months before and after the onset of symptoms.

Symptoms of illness, when present, generally begin about 90 days after infection. Initial symptoms (prodromal phase), which last from 3 to 10 days, are malaise, fever, headache, and myalgia. These symptoms are followed by the icteric phase. The icteric phase lasts 1 to 3 weeks and is characterized by jaundice, light or gray stools, and liver tenderness. As a person recovers, malaise and fatigue may persist for weeks or months. However, most infected infants and children have no symptoms and about 50% of infected adults also have no symptoms.

About 5% of all acute HBV infections progress to chronic infection. The risk of chronic infection is greatest in infants and younger children. For example, 30% to 50% of children infected with HBV between 1 year and 5 years of age become chronically infected. In contrast, only 5% of adults become chronically infected. People who are chronically infected do not have symptoms, but they are able to spread HBV to others and are called carriers. In addition, about 25% of persons with chronic HBV infection die prematurely from cirrhosis or liver cancer.

About the Vaccine

There are two hepatitis B vaccines: Recombivax HB and Engerix-B. Both are inactivated recombinant vaccines. They are available in both adult and pediatric formulations. In addition, Recombivax HB is available in a formulation for persons on dialysis. Hepatitis B vaccine is also commonly administered as a combination vaccine with DTaP, IPV, hepatitis A, and/or Hib vaccine.

Hepatitis B Vaccines Licensed for use in the US

Product: Engerix-B® (Hepatitis B)
Manufacturer: GlaxoSmithKline
Year licensed: 1989
Product Insert

Product Name: Recombivax HB® (Hepatitis B)
Manufacturer: Merck & Co
Year licensed: 1986
Product Insert

Combination Vaccines Containing Hepatitis B Vaccine Licensed for Use in the U.S.

Product Name: Comvax® (Hib and hepatitis B)
Manufacturer: Merck & Co
Year licensed: 1996
Product Insert

Product Name: Pediarix® (IPV, DTaP, and hepatitis B)
Manufacturer: GlaxoSmithKline
Year licensed: 2002
Product Insert

Product Name: Twinrix® (Hepatitis A and hepatitis B)
Manufacturer: GlaxoSmithKline
Year licensed: 2001
Product Insert

Indications Contraindications and precautions
Child
  • All children should receive their first dose of hepatitis B vaccine at birth and have a complete vaccine series by 6-18 months of age.
  • Children and adolescents through 18 years of age who did not receive the vaccine then they were younger should also be vaccinated.
Adult

All unvaccinated adults at risk for HBV infection should be vaccinated. This includes:

  • military personnel
  • men who have sex with men
  • people with more than one sex partner within 6 months
  • people who inject street drugs
  • people with chronic liver or kidney disease
  • people who have jobs that expose them to human blood
  • household contacts and sexual partners of people infected with HBV
  • residents and staff in institutions for persons with developmental disabilities
  • people who travel to countries where hepatitis B is common
  • people with HIV infection
  • people recently diagnosed with a sexually transmitted disease
  • people 19 through 59 years of age with diabetes mellitus *
  • anyone else who wants to be protected from HBV infection
  • People who have had a severe allergic reaction to a previous dose of hepatitis B vaccine or a hepatitis B vaccine component.* If you are administering hepatitis B combined with other vaccines (DTaP, Hib, hepatitis A, and/or polio) also check for a history of severe allergic reaction to a previous dose of these vaccines.
  • People who are moderately or severely ill should wait until recovery before receiving any vaccine. Minor illnesses, such as a cold, are not a contraindication.

* Hepatitis B vaccine may be administered at the discretion of the healthcare provider to unvaccinated adults with diabetes mellitus who are 60 years of age and older.

* Some products may contain yeast, neomycin, and aluminum hydroxide. The tip cap and the rubber plunger of the needless prefilled syringes may contain dry natural latex rubber.

Child
Vaccine Ages Dose/Route Routine Administration Schedule Previously unvaccinated infants and children (catch-up)
Engerix-B® Birth - 19 years of age Dose: 0.5 mL (10 mcg)
Route: Intramuscular (IM)
0, 1-2, 6-18 months 0, 1, 4 months (dose 3 must be given at least 16 weeks after dose 1)
Recombivax-HB® Birth - 19 years of age Dose: 0.5 mL (5 mcg)
Route: Intramuscular (IM)
0, 1-2, 6-18 months 0, 1, 4 months (dose 3 must be given at least 16 weeks after dose 1)
11 - 15 years of age Dose: 1 mL (10 mcg)
Route: Intramuscular (IM)
0, 4-6 months  
Comvax® (Hib and Hep B) 6 weeks - 15 months of age Dose: 0.5 mL
Route: Intramuscular (IM)
2, 4, 12-15 months of age Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered Comvax at ages 2, 4, and 12-15 months.
Pediarix® (DTaP, IPV, and Hep B) 6 weeks - 6 years of age Dose: 0.5 mL
Route: Intramuscular (IM)
2, 4, 6 months of age A child who is behind schedule can still receive Pediarix as long as it is given for doses 1, 2, or 3 of the series, and the child is younger than 7 years of age.
Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered Pediarix at ages 2, 4, and 6 months.
Adult
Vaccine Ages Dose/Route Routine Administration Schedule Previously unvaccinated infants and children (catch-up)
Engerix-B® 20 years of age and older (not on dialysis) Dose: 1 mL (20 mcg)
Route: Intramuscular (IM)
0, 1, 4-6 months The minimum interval between the second and third doses is 8 weeks. However, the first and third doses must be separated by at least 16 weeks.
20 years of age and older (on dialysis) Dose: 2 mL (40 mcg) - dialysis formulation
Route: Intramuscular (IM)
0, 1,2, 6 months (may need additional doses based on immune response)  
Recombivax-HB® 20 years of age and older (not on dialysis) Dose: 1 mL (10 mcg)
Route: Intramuscular (IM)
0, 1, 4-6 months The minimum interval between the second and third doses is 8 weeks. However, the first and third doses must be separated by at least 16 weeks.
20 years of age and older (on dialysis) Dose: 1 mL (40 mcg) - dialysis formulation
Route: Intramuscular (IM)
0, 1, 6 months (may need additional doses based on immune response)  
Twinrix® (Hep A and Hep B) 18 years of age and older Dose: 1 mL
Route: Intramuscular (IM)
0, 1, 6 months 0, 7, and 21 to 31 days with a booster dose at 12 months (if an accelerated schedule is necessary)
Hepatitis B Vaccine Side Effects*
  • Pain at the injection site in up to 29% of adults and 9% of children
  • Fatigue, headaches, irritability in up to 17% of adults and 20% of children
  • Temperature up to 37.7°C (99.9°F) in 1% of adults and up to 6.4% of children
  • Severe allergic reaction (very rare)

Notes:
*When hepatitis B antigens are given in combination with other antigens in one vaccine, the other antigens in the vaccine may cause other side effects. For more information about these possible side effects, go to the Hepatitis A, Pertussis, Diphtheria, Tetanus, Hib, and Polio pages.

Product Name Supplied Storage and Handling
Engerix-B
GlaxoSmithKline
In pediatric doses of 0.5 mL single dose vials (10 per package) and 0.5 mL single dose prefilled syringes (1, 5, or 10 per package). In adult doses of 1 ml single dose vials (10 per package)and 1 mL single dose prefilled syringes (10 per package). Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Engerix-B is a slightly turbid white suspension. Shake vial/syringe well before administering.
Recombivax HB
Merck & Co.
In pediatric doses of 0.5 mL single dose vials (1 or 10 per package) and 0.5 mL single dose prefilled syringes (6 per package). In adult doses of 1 ml single dose vials (1 or 10 per package) and 1 mL single dose prefilled syringes (6 per package). In dialysis formulation of 1 mL single dose vials (1 per package). Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Recombivax HB is a slightly turbid white suspension. Shake vial/syringe well before administering. Thorough agitation is needed to maintain suspension of the vaccine.
Comvax
Merck & Co.
0.5 mL single dose vials (10 per package) Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Comvax is a slightly opaque, white suspension containing inactive HIB and hepatitis B antigens. Shake well before administering. Look at consistency and coloring and discard if foreign particles are present.
Pediarix
GlaxoSmithKline
0.5 mL single dose prefilled syringes (10 per package) Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Pediarix should appear as a homogeneous, turbid, white suspension after the vial/syringe is shaken vigorously.
Twinrix
GlaxoSmithKline
1 mL single dose vials (10 per package) and 1 mL single dose prefilled syringes (1, 5, or 10 per package). Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Twinrix is a sterile white, cloudy suspension. Shake vial/syringe well before administering. Thorough agitation is needed to maintain suspension of the vaccine. 
Department of Defense Education Activity (DoDEA) - Immunization Requirements 2016-2017
A comprehensive guide for implementing the hepatitis B birth dose
Immunization Action Coalition
MSMR August 2012: Hospitalizations for Hepatitis A, B, and C, Active Component, U.S. Armed Forces,1991-2011
Department of Defense Education Activity (DoDEA) - Immunization Requirements 2016-2017
Author: Chu
DoD Instruction 6025.19
III MEF PDF 04 Jan 16
III MEF FORCE HEALTH PROTECTION (FHP) REQUIREMENTS 2016 (UPDATE)
02 Jan 14

Sample Q&A: The Disease

How do I know if I have or have had hepatitis B infection?

The only way to know if you are currently infected with hepatitis B, have recovered, are chronically infected, or are susceptible, is by having blood tests. The three standard blood tests are the following:

  1. HBsAg (hepatitis B surface antigen): when this test is "positive" or "reactive," it means the person is currently infected with hepatitis B and is able to pass the infection on to others.
  2. Anti-HBc [or HBc-Ab] (antibody to hepatitis B core antigen): when this test is "positive" or "reactive," it may mean the person has had contact with hepatitis B. This is a very complicated test to explain because the "anti-HBc" could possibly be a "false-positive" test result. The interpretation of this positive test usually depends on the results of the other two blood tests. Blood banks routinely run an "anti-HBc," but they do not routinely run an "anti-HBs."
  3. Anti-HBs [or HBs-Ab] (antibody to hepatitis B surface antigen): when this test is "positive" or "reactive," it means the person is immune to hepatitis B infection, either from immunization or from past infection. If the person was previously infected, he or she cannot pass the disease on to others. Remember, this test is not routinely done by blood banks.
Interpretation of the Hepatitis B Blood Test Results
Tests Results Interpretation
HBsAg negative Susceptible to hepatitis B infection
anti-HBc negative
anti-HBs negative
HBsAg negative Immune due to immunization
anti-HBc negative
anti-HBs positive with >10mIU/mL*
HBsAg negative Immune due to infection with hepatitis B
anti-HBc positive
anti-HBs positive
HBsAg positive Newly infected with hepatitis B virus
anti-HBc positive
IgM anti-HBc positive
anti-HBs negative
HBsAg positive Chronically infected with hepatitis B virus
anti-HBc positive
IgM anti-HBc negative
anti-HBs negative
HBsAg negative Four interpretations possible†
anti-HBc positive
anti-HBs negative
  • * Post-immunization testing, when it is recommended, should be done 1 to 2 months after the final dose.
  • †, 1.May be recovering from acute hepatitis B infection.
  • 2. May be distantly immune and the test is not sensitive enough to detect a very low level of anti-HBs in serum.
  • 3. May be susceptible with a "false positive" anti-HBc.
  • 4. May be chronically infected and have an undetectable level of HBsAg present in the serum.
Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of Adults
Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP), Part II: Immunization of Adults
A comprehensive guide for implementing the hepatitis B birth dose
Immunization Action Coalition
MSMR August 2012: Hospitalizations for Hepatitis A, B, and C, Active Component, U.S. Armed Forces,1991-2011
Centers for Disease Control and Prevention
Division of Viral Hepatitis
New NDC for GSK Hepatitis B Vaccine (Recombinant) in Prefilled Tip-Lok® Syringe
Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP), Part II: Immunization of Adults
Department of Defense Education Activity (DoDEA) - Immunization Requirements 2016-2017
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Package Insert - Vaccine
Package Insert - Vaccine
Package Insert - Vaccine
Package Insert - Vaccine
Comvax (Merck) 01 Dec 10
Package Insert - Vaccine
Hepatitis B Recommendations for Adults
MMQC-13-1630 03 Jul 13
RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] / Merck Sharp & Dohme / DLA 13-242
New NDC for GSK Hepatitis B Vaccine (Recombinant) in Prefilled Tip-Lok® Syringe
VIS
Vaccine Information Statement - Hepatitis B Vaccine.
Author(s): Hadler S, de Monzon MA, Lugo DR, Perez M
Publication: Vaccine, vol. 7
Subject: Vaccine-Safety
Disease: 
Hepatitis B
Author(s): Marsano LS, West DJ, Chant I, Hesley TM, Cox J, Hackworth V, Greenberg RN
Publication: Vaccine. Vol. 16. No. 6, pp. 624-629
Subject: Vaccine-Effectiveness
Disease: 
Hepatitis B
Author(s): Jilg W, Schmidt M, Deinhardt F
Publication: Journal d Medical Virology 17:249-254
Subject: Vaccine-Effectiveness
Disease: 
Hepatitis B
Author(s): Wistrom J, Ahlm C, Lundberg S, Settergren B, Tarnvik A
Publication: Vaccine 17 (1999) 2162-2165
Subject: Vaccine-Effectiveness
Disease: 
Hepatitis B