- What is Hepatitis B
- What is Acute Hepatitis B vs. Chronic Hepatitis B
- How many new hepatitis B virus infections occur annually in the United States ?
- How is Hepatitis B Transmitted
- Prevention of Hepatitis B virus (HBV) infection
- What are the signs and symptoms of Hepatitis B virus (HBV) infection ?
- Hepatitis B virus (HBV) Diagnosis
- Hepatitis B Serology
- How do I interpret hepatitis B serologic test results ?
- How is Hepatitis B virus (HBV) infection treated ?
- Hepatitis B Vaccine
- Who should be vaccinated against hepatitis B ?
- Is hepatitis B vaccination recommended in certain settings ?
- Who should not receive hepatitis B vaccine ?
- Can hepatitis B vaccine be given during pregnancy or lactation ?
- Can hepatitis B vaccine be given after exposure to Hepatitis B virus (HBV) ?
- What are the hepatitis B vaccines licensed for use in the United States ?
- Hepatitis B vaccine side effects
- What are the recommended schedules for hepatitis B vaccination ?
- What are the recommended doses of hepatitis B vaccines ?
- Is it harmful to administer an extra dose(s) of Hepatitis A or hepatitis B vaccine or to repeat the entire vaccine series if documentation of vaccination history is unavailable ?
- If there is an interruption between doses of hepatitis B vaccine, does the vaccine series need to be restarted ?
- Can hepatitis B vaccine be administered concurrently with other vaccines ?
- How long does protection from hepatitis B vaccine last ?
- Why should an infant receive hepatitis B vaccine at birth before hospital discharge, even if the mother is negative for hepatitis B surface antigen (HBsAg) ?
- Can hepatitis B vaccine be given to immunocompromised persons, such as persons on hemodialysis or persons with HIV infection ?
- Can a patient receive the first dose of hepatitis B vaccine from one manufacturer and subsequent doses from another manufacturer ?
- Is there any benefit or risk in vaccinating a person who has been infected with Hepatitis B virus (HBV) ?
- Should persons be tested for immunity to hepatitis B before being vaccinated ?
- Who should receive post-vaccination testing ?
- When should postvaccination testing be done ?
- Are booster doses of hepatitis B vaccine recommended ?
What is Hepatitis B
Hepatitis B is a liver infection caused by the Hepatitis B virus (HBV) 1). Hepatitis B is transmitted when blood, semen, or another body fluid from a person infected with the Hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth 2). For some people, hepatitis B is an acute or short-term, illness but for others if it does not get better, hepatitis B can become a long-term, chronic hepatitis B infection, which lasts a lifetime. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic Hepatitis B can lead to serious health issues, like cirrhosis (scarring of the liver), liver failure or liver cancer. People with chronic hepatitis B may also develop kidney disease or inflammation of blood vessels.
If you get hepatitis B virus (HBV), you may feel as if you have the flu. You may also have jaundice, a yellowing of skin and eyes, dark-colored urine, and pale bowel movements. Some people have no symptoms at all. A blood test can tell if you have it.
A vaccine against hepatitis B has been available since 1982 3). The vaccine is 95% effective in preventing infection and the development of chronic hepatitis B infection and liver cancer due to hepatitis B. The best way to prevent Hepatitis B is by getting vaccinated. It requires three shots. All babies should get the hepatitis B vaccine, but older children and adults can get it too. If you travel to countries where Hepatitis B is common, you should get the vaccine.
Hepatitis B prevalence is highest in the World Health Organization (WHO) Western Pacific Region and the World Health Organization (WHO) African Region, where 6.2% and 6.1% respectively of the adult population is infected. In the WHO Eastern Mediterranean Region, the WHO South-East Asia Region and the WHO European Region, an estimated 3.3%, 2.0% and 1.6%% of the general population is infected, respectively. 0.7% of the population of the WHO Region of the Americas is infected.
Hepatitis B virus (HBV) and Human Immunodeficiency virus (HIV) coinfection
According to the World Health Organization (WHO) about 1% of persons living with hepatitis B virus (HBV) infection (2.7 million people) are also infected with human Immunodeficiency virus (HIV) 4). Conversely, the global prevalence of hepatitis B virus (HBV) infection in human Immunodeficiency virus (HIV)-infected persons is 7.4%. Since 2015, WHO has recommended treatment for everyone diagnosed with human Immunodeficiency virus (HIV) infection, regardless of the stage of disease. Tenofovir, which is included in the treatment combinations recommended in first intention against human Immunodeficiency virus (HIV) infection, is also active against hepatitis B virus (HBV).
What is Acute Hepatitis B vs. Chronic Hepatitis B
Hepatitis B infection may be either short-lived (Acute) or long lasting (Chronic).
- Acute hepatitis B infection lasts less than six months. Your immune system likely can clear acute hepatitis B from your body, and you should recover completely within a few months. Most people who get hepatitis B as adults have an acute infection, but it can lead to chronic infection.
- Chronic hepatitis B infection lasts six months or longer. It lingers because your immune system can’t fight off the infection. Chronic hepatitis B infection may last a lifetime, possibly leading to serious illnesses such as cirrhosis, liver failure and liver cancer.
The younger you are when you get hepatitis B — particularly newborns or children younger than 5 — the higher your risk of the infection becoming chronic. Chronic infection may go undetected for decades until a person becomes seriously ill from liver disease.
How serious is Acute HBV infection ?
Acute infection ranges from asymptomatic or mild disease to — rarely — fulminant hepatitis. Disease is more severe among adults aged >60 years. The fatality rate among acute cases reported to the Centers for Disease Control and Prevention (CDC) is 0.5%–1%.
How serious is Chronic hepatitis B virus (HBV) infection ?
Approximately 25% of those who become chronically infected during childhood and 15% of those who become chronically infected after childhood die prematurely from cirrhosis or liver cancer, and the majority remain asymptomatic until onset of cirrhosis or end-stage liver disease. In the United States, chronic hepatitis B virus (HBV) infection results in an estimated 1,800 deaths per year.
How likely is hepatitis B virus (HBV) infection to become chronic ?
The risk for chronic infection varies according to the age at infection and is greatest among young children. Approximately 90% of infants and 25%–50% of children aged 1–5 years will remain chronically infected with hepatitis B virus (HBV). By contrast, approximately 95% of adults recover completely from hepatitis B virus (HBV) infection and do not become chronically infected.
How many new hepatitis B virus infections occur annually in the United States ?
In 2014, a total of 2,953 cases of acute hepatitis B were reported from 48 states to the Centers for Disease Control and Prevention (CDC). The overall incidence rate for 2014 was 0.9 cases per 100,000 population. After adjusting for under-ascertainment and under-reporting, an estimated 19,200 acute hepatitis B cases occurred in 2014.
Figure 1. Acute Hepatitis B virus (HBV) incidence rate
Has the rate of new hepatitis B virus infections in the United States declined ?
The rate of new hepatitis B virus infections has declined by approximately 82% since 1991, when a national strategy to eliminate hepatitis B virus infection was implemented in the United States. The decline has been greatest among children born since 1991, when routine vaccination of children was first recommended.
How common is Chronic Hepatitis B virus infection in the United States ?
An estimated 850,000–2.2 million persons in the United States have chronic hepatitis B virus infection. Chronic infection is an even greater problem globally, affecting approximately 240 million persons 5). An estimated 786,000 persons worldwide die from hepatitis B virus -related liver disease each year 6).
How is Hepatitis B Transmitted
Hepatitis B virus (HBV) is transmitted through activities that involve percutaneous (i.e., puncture through the skin) or mucosal contact with infectious blood and various body fluids, as well as through saliva, menstrual, vaginal, and seminal fluids, including:
- Sex with an infected partner
- Injection drug use that involves sharing needles, syringes, or drug-preparation equipment
- Birth to an infected mother. Pregnant women infected with HBV can pass the virus to their babies during childbirth. However, the newborn can be vaccinated to avoid getting infected in almost all cases. Talk to your doctor about being tested for hepatitis B if you are pregnant or want to become pregnant.
- Contact with blood or open sores of an infected person
- Needle sticks or sharp instrument exposures
- Sharing items such as razors or toothbrushes with an infected person
Sexual transmission of hepatitis B may occur, particularly in unvaccinated men who have sex with men and heterosexual persons with multiple sex partners or contact with sex workers.
Hepatitis B virus (HBV) is not spread through food or water, sharing eating utensils, breastfeeding, hugging, kissing, hand holding, coughing, or sneezing.
How long does Hepatitis B virus (HBV) survive outside the body ?
Hepatitis B virus can survive outside the body at least 7 days and still be capable of causing infection.
What should be used to remove hepatitis B virus from environmental surfaces ?
Any blood spills — including dried blood, which can still be infectious — should be cleaned using 1:10 dilution of one part household bleach to 10 parts of water for disinfecting the area. Gloves should be used when cleaning up any blood spills.
Who is at risk for hepatitis B virus infection ?
The following populations are at increased risk of becoming infected with hepatitis B virus:
- Infants born to infected mothers
- Sex partners of infected persons
- Sexually active persons who are not in a long-term, mutually monogamous relationship (e.g., >1 sex partner during the previous 6 months)
- Men who have sex with men
- Injection drug users
- Household contacts of persons with chronic hepatitis B virus infection
- Health care and public safety workers at risk for occupational exposure to blood or blood-contaminated body fluids
- Hemodialysis patients
- Residents and staff of facilities for developmentally disabled persons
- Travelers to countries with intermediate or high prevalence of hepatitis B virus infection
Are international travelers at risk for hepatitis B virus infection ?
The risk for hepatitis B virus infection in international travelers is generally low, except for certain travelers to regions where the prevalence of chronic hepatitis B virus infection is high or intermediate (i.e., hepatitis B surface antigen prevalence of ≥2%). Hepatitis B vaccination should be administered to unvaccinated persons traveling to those countries.
More information about hepatitis B and travel is available from CDC’s Travelers’ Health site 7).
Prevention of Hepatitis B virus (HBV) infection
The hepatitis B vaccine is typically given as three or four injections over six months. You can’t get hepatitis B from the vaccine.
The hepatitis B vaccine is recommended for:
- Children and adolescents not vaccinated at birth
- Those who work or live in a center for people who are developmentally disabled
- People who live with someone who has hepatitis B
- Health care workers, emergency workers and other people who come into contact with blood
- Anyone who has a sexually transmitted infection, including HIV
- Men who have sex with men
- People who have multiple sexual partners
- Sexual partners of someone who has hepatitis B
- People who inject illegal drugs or share needles and syringes
- People with chronic liver disease
- People with end-stage kidney disease
- Travelers planning to go to an area of the world with a high hepatitis B infection rate
Take precautions to avoid Hepatitis B virus (HBV)
Other ways to reduce your risk of Hepatitis B virus (HBV) include:
- Know the Hepatitis B virus (HBV) status of any sexual partner. Don’t engage in unprotected sex unless you’re absolutely certain your partner isn’t infected with hepatitis B virus or any other sexually transmitted infection.
- Use a new latex or polyurethane condom every time you have sex if you don’t know the health status of your partner. Remember that although condoms can reduce your risk of contracting hepatitis B virus, they don’t eliminate the risk.
- Don’t use illegal drugs. If you use illicit drugs, get help to stop. If you can’t stop, use a sterile needle each time you inject illicit drugs. Never share needles.
- Be cautious about body piercing and tattooing. If you get a piercing or tattoo, look for a reputable shop. Ask about how the equipment is cleaned. Make sure the employees use sterile needles. If you can’t get answers, look for another shop.
- Ask about the hepatitis B vaccine before you travel. If you’re traveling to a region where hepatitis B is common, ask your doctor about the hepatitis B vaccine in advance. It’s usually given in a series of three injections over a six-month period.
Screening healthy people for hepatitis B
Doctors sometimes test certain healthy people for hepatitis B infection because the virus can damage the liver before causing signs and symptoms. Talk to your doctor about screening for hepatitis B infection if you:
- Are pregnant
- Live with someone who has hepatitis B
- Have had many sexual partners
- Have had sex with someone who has hepatitis B
- Are a man who has sex with men
- Have a history of a sexually transmitted illness
- Have HIV or hepatitis C
- Have a liver enzyme test with unexplained abnormal results
- Receive kidney dialysis
- Take medications that suppress the immune system, such as those used to prevent rejection after an organ transplant
- Use illegal injected drugs
- Are in prison
- Were born in a country where hepatitis B is common, including Asia, the Pacific Islands, Africa and Eastern Europe
- Have parents or adopted children from places where hepatitis B is common, including Asia, the Pacific Islands, Africa and Eastern Europe
What are the signs and symptoms of Hepatitis B virus (HBV) infection ?
The presence of signs and symptoms varies by age. Most children under age 5 years and newly infected immunosuppressed adults are asymptomatic, whereas 30%–50% of persons aged ≥5 years have initial signs and symptoms.
When present, signs and symptoms can include:
- Loss of appetite
- Abdominal pain
- Dark urine
- Clay-colored bowel movements
- Joint pain
- Jaundice: yellowing of your skin and the whites of your eyes
Persons with chronic hepatitis B virus infection might be asymptomatic, have no evidence of liver disease, or have a spectrum of disease ranging from chronic hepatitis to cirrhosis or hepatocellular carcinoma (a type of liver cancer).
When to see a doctor
If you know you’ve been exposed to hepatitis B, contact your doctor immediately. A preventive treatment may reduce your risk of infection if you receive the treatment within 24 hours of exposure to the virus.
If you think you have signs or symptoms of hepatitis B, see your doctor.
What is the incubation period for hepatitis B ?
The incubation period of the hepatitis B virus is 75 days on average, but can vary from 30 to 180 days. The virus may be detected within 30 to 60 days after infection and can persist and develop into chronic hepatitis B.
Symptoms begin an average of 90 days (range: 60–150 days) after exposure to hepatitis B virus (HBV).
When symptoms of acute hepatitis B occur, how long do they usually last ?
Symptoms typically last for several weeks but can persist for up to 6 months.
Hepatitis B virus (HBV) Diagnosis
Your doctor will examine you and look for signs of liver damage, such as yellowing skin or belly pain. Tests that can help diagnose hepatitis B or its complications are:
- Blood tests and Hepatitis Serology. Blood tests can detect signs of the hepatitis B virus in your body and tell your doctor whether it’s acute or chronic. A simple blood test can also determine if you’re immune to the condition.
- Liver ultrasound. A special ultrasound called transient elastography can show the amount of liver damage.
- Liver biopsy. Your doctor might remove a small sample of your liver for testing (liver biopsy) to check for liver damage. During this test, your doctor inserts a thin needle through your skin and into your liver and removes a tissue sample for laboratory analysis.
Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg.
- Acute hepatitis B virus infection is characterized by the presence of HBsAg and immunoglobulin M (IgM) antibody to the core antigen, HBcAg. During the initial phase of infection, patients are also seropositive for hepatitis B e antigen (HBeAg). HBeAg is usually a marker of high levels of replication of the virus. The presence of HBeAg indicates that the blood and body fluids of the infected individual are highly infectious.
- Chronic infection is characterized by the persistence of HBsAg for at least 6 months (with or without concurrent HBeAg). Persistence of HBsAg is the principal marker of risk for developing chronic liver disease and liver cancer (hepatocellular carcinoma) later in life.
How long does it take for blood to test HBsAg-positive after exposure to Hepatitis B virus (HBV) ?
HBsAg will be detected in an infected person’s blood an average of 4 weeks (range: 1–9 weeks) after exposure to the virus. About 1 of 2 patients will no longer be infectious by 7 weeks after onset of symptoms and all patients who do not remain chronically infected will be HBsAg-negative by 15 weeks after onset of symptoms.
Hepatitis B Serology
What do the different hepatitis B serologic markers mean ?
Hepatitis B surface antigen (HBsAg)
A protein on the surface of Hepatitis B virus (HBV); it can be detected in high levels in serum during acute or chronic Hepatitis B virus (HBV) infection. The presence of HBsAg indicates that the person is infectious. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. HBsAg is the antigen used to make hepatitis B vaccine.
Hepatitis B surface antibody (anti-HBs)
The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus (HBV) infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B.
Total hepatitis B core antibody (anti-HBc)
Appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with hepatitis B virus in an undefined time frame.
IgM antibody to hepatitis B core antigen (IgM anti-HBc)
Positivity indicates recent infection with hepatitis B virus (≤6 months). Its presence indicates acute infection.
Hepatitis B e antigen (HBeAg)
A secreted product of the nucleocapsid gene of hepatitis B virus that is found in serum during acute and chronic hepatitis B. Its presence indicates that the virus is replicating and the infected person has high levels of hepatitis B virus.
Hepatitis B e antibody (HBeAb or anti-HBe)
Produced by the immune system temporarily during acute hepatitis B virus infection or consistently during or after a burst in viral replication. Spontaneous conversion from e antigen to e antibody (a change known as seroconversion) is a predictor of long-term clearance of hepatitis B virus in patients undergoing antiviral therapy and indicates lower levels of hepatitis B virus .
How do I interpret hepatitis B serologic test results ?
|Interpretation of hepatitis B Serologic Test Results|
|Immune due to natural infection|
|Immune due to hepatitis B vaccination|
|Interpretation unclear; four possibilities:|
1. Resolved infection (most common)
2. False-positive anti-HBc, thus susceptible
3. “Low level” chronic infection
4. Resolving acute infection
hepatitis B surface antigen (HBsAg): A protein on the surface of HBV; it can be detected in high levels in serum during acute or chronic HBV infection. The presence of HBsAg indicates that the person is infectious. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. HBsAg is the antigen used to make hepatitis B vaccine.
hepatitis B surface antibody (anti-HBs): The presence of anti-HBs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B.
Total hepatitis B core antibody (anti-HBc): Appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with HBV in an undefined time frame.
IgM antibody to hepatitis B core antigen (IgM anti-HBc): Positivity indicates recent infection with HBV (≤6 months). Its presence indicates acute infection.
Adapted from: A Comprehensive Immunization Strategy to Eliminate Transmission of hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. Part I: Immunization of Infants, Children, and Adolescents. MMWR 2005;54(No. RR-16).
How is Hepatitis B virus (HBV) infection treated ?
Treatment for acute hepatitis B infection
If your doctor determines your hepatitis B infection is acute — meaning it is short-lived and will go away on its own — you may not need treatment. Instead, your doctor might recommend rest, proper nutrition and plenty of fluids while your body fights the infection and including replacement of fluids lost from vomiting and diarrhea. In severe cases, antiviral drugs or a hospital stay is needed to prevent complications.
Treatment to prevent hepatitis B infection after exposure
If you know you’ve been exposed to the hepatitis B virus and aren’t sure if you’ve been vaccinated, call your doctor immediately. An injection of immunoglobulin (an antibody) given within 12 hours of exposure to the virus may help protect you from getting sick with hepatitis B. Because this treatment only provides short-term protection, you also should get the hepatitis B vaccine at the same time, if you never received it.
Treatment for chronic hepatitis B infection
In most people, the treatment does not cure hepatitis B infection, but only suppresses the replication of the virus. Therefore, most people with chronic hepatitis B infection must treatment for the rest of their lives. Treatment helps reduce the risk of liver disease and prevents you from passing the infection to others. Treatment for chronic hepatitis B may include:
- Antiviral medications. Several antiviral medications — including entecavir (Baraclude), tenofovir (Viread), lamivudine (Epivir), adefovir (Hepsera) and telbivudine (Tyzeka) — can help fight the virus and slow its ability to damage your liver. These drugs are taken by mouth. Talk to your doctor about which medication might be right for you.
- Interferon injections. Interferon alfa-2b (Intron A) is a man-made version of a substance produced by the body to fight infection. It’s used mainly for young people with hepatitis B who wish to avoid long-term treatment or women who might want to get pregnant within a few years, after completing a finite course of therapy. Interferon should not be used during pregnancy. Side effects may include nausea, vomiting, difficulty breathing and depression.
- Liver transplant. If your liver has been severely damaged, a liver transplant may be an option. During a liver transplant, the surgeon removes your damaged liver and replaces it with a healthy liver. Most transplanted livers come from deceased donors, though a small number come from living donors who donate a portion of their livers.
Other drugs to treat hepatitis B are being developed.
Hepatitis B Vaccine
Who should be vaccinated against hepatitis B ?
The Advisory Committee on Immunization Practices recommends that the following persons be vaccinated against hepatitis B:
- All infants, beginning at birth
- All children aged <19 years who have not been vaccinated previously
- Susceptible sex partners of hepatitis B surface antigen (HBsAg)-positive persons
- Sexually active persons who are not in a long-term, mutually monogamous relationship (e.g., >1 sex partner during the previous 6 months)
- Persons seeking evaluation or treatment for a sexually transmitted disease
- Men who have sex with men
- Injection drug users
- Susceptible household contacts of HBsAg-positive persons
- Health care and public safety workers at risk for exposure to blood or blood-contaminated body fluids
- Persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients
- Residents and staff of facilities for developmentally disabled persons
- Travelers to regions with intermediate or high rates of endemic HBV infection
- Persons with chronic liver disease
- Persons with HIV infection
- Unvaccinated adults with diabetes mellitus who are aged 19 through 59 years (discretion of clinicians for unvaccinated adults with diabetes mellitus who are aged ≥60 years)
- All other persons seeking protection from HBV infection — acknowledgment of a specific risk factor is not a requirement for vaccination
Is hepatitis B vaccination recommended in certain settings ?
Yes. In certain health care, evaluation, or treatment settings, a high proportion of clients have known risk factors for Hepatitis B virus infection. The Advisory Committee on Immunization Practices recommends universal vaccination of adults who receive care in those settings, including:
- Sexually transmitted disease treatment facilities
- HIV testing and treatment facilities
- Facilities providing drug-abuse treatment and prevention services
- Health care settings targeting services to injection drug users
- Correctional facilities
- Health care settings targeting services to men who have sex with men
- Chronic hemodialysis facilities and end-stage renal disease programs
- Institutions and nonresidential day care facilities for developmentally disabled persons.
Who should not receive hepatitis B vaccine ?
Anyone who has had a serious allergic reaction to a prior dose of hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive hepatitis B vaccine.
Can hepatitis B vaccine be given during pregnancy or lactation ?
Yes. hepatitis B vaccine contains no live virus, so neither pregnancy nor lactation should be considered a contraindication to vaccination of women. On the basis of limited experience, there is no apparent risk of adverse effects to developing fetuses when hepatitis B vaccine is administered to pregnant women. Meanwhile, new Hepatitis B virus (HBV) infection in a pregnant woman might result in severe disease for the mother and chronic infection for the newborn.
Can hepatitis B vaccine be given after exposure to Hepatitis B virus (HBV) ?
Yes. After a person has been exposed to hepatitis B virus, appropriate prophylaxis, given as soon as possible but preferably within 24 hours, can effectively prevent infection. The mainstay of postexposure immunoprophylaxis is hepatitis B vaccine, but in certain circumstances the addition of hepatitis B immune globulin (HBIG) will provide increased protection.
What are the hepatitis B vaccines licensed for use in the United States ?
Two single-antigen vaccines and three combination vaccines are currently licensed in the United States.
Single-antigen hepatitis B vaccines
- RECOMBIVAX HB®
- PEDIARIX®: Combined hepatitis B, diphtheria, tetanus, acellular pertussis (DTaP), and inactivated poliovirus (IPV) vaccine. Cannot be administered before age 6 weeks or after age 7 years.
- TWINRIX®: Combined Hepatitis A and hepatitis B vaccine. Recommended for persons aged ≥18 years who are at increased risk for both Hepatitis A virus and HBV infections.
- COMVAX® (discontinued for purchase as of December 2014): Combined hepatitis B-Haemophilus influenzae type b (Hib) conjugate vaccine. Cannot be administered before age 6 weeks or after age 71 months.
Hepatitis B vaccine side effects
On the basis of Vaccine Safety Datalink data, the estimated incidence of anaphylaxis among children and adolescents who received hepatitis B vaccine is one case per 1.1 million vaccine doses distributed 10).
What are the recommended schedules for hepatitis B vaccination ?
- The vaccination schedule most often used for children and adults is 3 intramuscular injections, the second and third doses administered 1 and 6 months, respectively, after the first dose.
Alternate schedules have been approved for certain vaccines and/or populations.
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2017
Hepatitis B vaccine (Updated 3/6/2017):
- Monovalent Hepatitis B vaccine should be administered within 24h of birth for medically stable infants weighing ≥2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers. The recommendations for vaccination of infants <2,000 grams (as well as infants born to HBsAg-positive mothers or mothers whose hepatitis B status is unknown) remain unchanged.
- Preterm infants weighing <2,000 g born to HBsAg-negative mothers should receive the first dose of vaccine 1 month after birth or at hospital discharge.
What are the recommended doses of hepatitis B vaccines ?
|Recommended doses of currently licensed formulations of hepatitis B vaccine, by age group and vaccine type|
|Age Group||Single-antigen vaccine||Combination vaccine|
|Dose (μg)||Vol (mL)||Dose (μg)||Vol (mL)||Dose (μg)||Vol (mL)||Dose (μg)||Vol (mL)||Dose (μg)||Vol (mL)|
|Infants (<1 yr)||5||0.5||10||0.5||5||0.5||10||0.5||NA**||NA|
|Children (1–10 yrs)||5||0.5||10||0.5||5*||0.5||10†||0.5||NA||NA|
|Adults (≥20 yrs)||10||10||20||1.0||NA||NA||NA||NA||20§||1.0|
and other immuno-
* Combined hepatitis B–Haemophilus influenzae type b conjugate vaccine. This vaccine cannot be administered at birth, before age 6 weeks, or after age 71 months.
† Combined hepatitis B, diphtheria, tetanus, acellular pertussis adsorbed, inactivated poliovirus vaccine. This vaccine cannot be administered at birth, before age 6 weeks, or at age >7 years.
§ Combined Hepatitis A and hepatitis B vaccine. This vaccine is recommended for persons aged ≥18 years who are at increased risk for both hepatitis B virus and Hepatitis A virus infections.
¶ Recombinant hepatitis B surface antigen protein dose.
** Not applicable.
†† Adult formulation administered on a 2-dose schedule.
§§ Higher doses might be more immunogenic, but no specific recommendations have been made.
¶¶ Dialysis formulation administered on a 3-dose schedule at 0, 1, and 6 months.
*** Two 1.0-mL doses administered at one site, on a 4-dose schedule at 0, 1, 2, and 6 months.
No. If necessary, administering extra doses of Hepatitis A or hepatitis B vaccine is not harmful.
No, the series does not need to be restarted.
- If the vaccine series was interrupted after the first dose, the second dose should be administered as soon as possible.
- The second and third doses should be separated by an interval of at least 8 weeks.
- If only the third dose is delayed, it should be administered as soon as possible.
Can hepatitis B vaccine be administered concurrently with other vaccines ?
Yes. When hepatitis B vaccine has been administered at the same time as other vaccines, no interference with the antibody response of the other vaccines has been demonstrated. Separate body sites and syringes should be used for simultaneous administration of injectable vaccines.
How long does protection from hepatitis B vaccine last ?
Studies indicate that immunologic memory remains intact for at least 20 years among healthy vaccinated individuals who initiated hepatitis B vaccination >6 months of age. The vaccine confers long-term protection against clinical illness and chronic hepatitis B virus infection. Cellular immunity appears to persist even though antibody levels might become low or decline below detectable levels.
Among vaccinated cohorts who initiated hepatitis B vaccination at birth, long-term follow-up studies are ongoing to determine the duration of vaccine-induced immunity.
Infants born to hepatitis B virus-infected mothers require hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth to protect them from infection. However, because errors or delays in documenting, testing, and reporting maternal HBsAg status can and do occur, administering the first dose of hepatitis B vaccine soon after birth to all infants acts as a safety net, reducing the risk for perinatal infection when maternal HBsAg status is either unknown or incorrectly documented at delivery. Also, initiating the hepatitis B vaccine series at birth has been shown to increase a child’s likelihood of completing the vaccine series on schedule.
Yes, although a larger vaccine dose is required to induce protective antibody in hemodialysis patients. Larger doses or additional doses might also be necessary for other immunocompromised persons. Serologic testing of hemodialysis patients and other immunocompromised persons is recommended 1–2 months after administration of the final dose of the primary vaccine series to determine the need for revaccination. Detailed guidance on vaccination of hemodialysis patients and other immunocompromised persons is available from the Advisory Committee on Immunization Practices recommendations on adult hepatitis B vaccination [available at 11)].
Yes. No differences in immune response are observed when vaccines from different manufacturers are used to complete the vaccine series.
Persons who have already been infected with Hepatitis B virus (HBV) will receive no benefit from vaccination. However, there is no risk to a previously infected person who receives vaccination.
Should persons be tested for immunity to hepatitis B before being vaccinated ?
Routine prevaccination testing for immunity has not been recommended because it has not generally been found to be cost-effective. However, in adult populations that have an expected high prevalence (>20%) of hepatitis B virus infection (e.g., IDUs and MSM, especially those in older age groups), conducting prevaccination serologic testing for susceptibility prior to or at the same time of the initial vaccine dose might be considered to be cost saving, by reducing the cost of the complete the vaccination series.
Prevaccination testing for susceptibility is recommended for foreign-born persons born in Africa, Asia, the Pacific Islands, and other regions with high endemicity of hepatitis B virus infection (HBsAg prevalence of ≥8%); unvaccinated household, sexual, and needle-sharing contacts of HBsAg-positive persons; and for HIV-infected persons. Serologic testing should not be a barrier to vaccination. The first vaccine dose should be administered immediately after collection of the blood sample for serologic testing. Vaccination of persons who are immune to hepatitis B virus infection because of current or previous infection or vaccination is not harmful and does not increase the risk for adverse events.
When a single test is used for prevaccination testing, anti-HBc is the test of choice. Persons who are anti-HBc–positive should be tested for HBsAg. If persons are determined to be HBsAg negative, no further action is required. Persons with positive HBsAg should be referred to a specialist in the management of hepatitis B infection and receive further serologic evaluation, prevention counseling, and evaluation for antiviral treatment.
Who should receive post-vaccination testing ?
Testing for immunity is advised only for persons whose subsequent clinical management depends on knowledge of their immune status, including
- Infants born to HBsAg-positive mothers
- Health care workers and public safety workers at high risk for continued percutaneous or mucosal exposure to blood or body fluids
- Chronic hemodialysis patients, HIV-infected persons, and other immunocompromised persons (e.g., hematopoietic stem-cell transplant recipients or persons receiving chemotherapy)
- Sex partners of persons with chronic hepatitis B virus infection
When should postvaccination testing be done ?
For infants born to HBsAg-positive mothers, postvaccination testing should be performed 1–2 months after completion of ≥3 doses of a licensed hepatitis B vaccine series (i.e., at age 9–12 months, generally at the next well-child visit). To avoid detection of anti-HBs from hepatitis B immune globulin administered during infancy and to maximize detection of late HBV infection, testing should not be performed before age 9 months nor within 4 weeks of the most recent vaccine dose.
Are booster doses of hepatitis B vaccine recommended ?
Booster doses of hepatitis B vaccine are recommended only in certain circumstances:
- For hemodialysis patients, the need for booster doses should be assessed by annual testing for antibody to hepatitis B surface antigen (anti-HBs). A booster dose should be administered when anti-HBs levels decline to <10 mIU/mL.
- For other immunocompromised persons (e.g., HIV-infected persons, hematopoietic stem-cell transplant recipients, and persons receiving chemotherapy), the need for booster doses has not been determined. When anti-HBs levels decline to <10 mIU/mL, annual anti-HBs testing and booster doses should be considered for those with an ongoing risk for exposure.
For persons with normal immune status who have been vaccinated, booster doses are not recommended.
References [ + ]
|1, 2.||↵||Hepatitis B FAQs for Health Professionals. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm|
|3, 4.||↵||Hepatitis B. http://www.who.int/mediacentre/factsheets/fs204/en/|
|5.||↵||World Health Organization. Media Centre: hepatitis B. July 2013. http://www.who.int/mediacentre/factsheets/fs204/en/|
|6.||↵||Lozano R, Naghavi M, Foreman K et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet 2012; 380: 2095-128.|
|8.||↵||Andre FE. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 1989;87(Suppl 3A):S14–20.|
|9.||↵||Greenberg DP. Pediatric experience with recombinant hepatitis B vaccines and relevant safety and immunogenicity studies. Pediatr Infect Dis J 1993;12:438–45.|