Why It Is Important To Do This Review
As unnecessary hepatitis B revaccination is wasteful, none of the international guidelines recommend booster doses to be applied universally . Furthermore, duration of protection provided by the hepatitis B vaccine is important for public health authorities who have to plan immunisation programmes and formulate future booster vaccination policies. Hence, protective immunity of the vaccine still requires further investigation . We found some review articles , and two metaanalyses that address the anamnestic immune response to a booster dose of hepatitis B vaccine . However, these metaanalyses were based on the results of observational studies rather than randomised clinical trials. This raises the risks of confounding and bias. In this systematic review, we aim to determine the longterm protection of hepatitis B vaccine and the need for a hepatitis B vaccine booster dose, using the results of randomised clinical trials.
Accelerated Us Children And Adult Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
In some instances, it may be necessary to vaccinate within a short period of time to ensure protection before travel. There are accelerated schedules to provide the highest level of protection over a short period of time. Individuals who need an accelerated schedule must have a booster dose at 1 year to ensure long-term protection. Note that the 2-dose Heplisav-B vaccine will also ensure maximum protection over a 1-month period without the need for a booster dose at 1 year.
4-Dose Vaccine Series for Children and Adults
Engerix-B is a 3-dose vaccine that can be given on an accelerated, four-dose schedule, with 3 shots administered within 2 months, and a booster dose at 1 year to provide maximum long-term protection.
4-Dose Combination Hepatitis A and B Vaccine Series
Twinrix is a 4-dose vaccine that can be given on an accelerated schedule to provide protection against hepatitis A and B. Three doses are administered within 1 month, followed by a booster shot at 1 year. This is a common choice of vaccine for those travelling on short-notice outside the U.S. It is important to complete the booster dose at 1 year, to ensure long-term protection.
2-Dose Vaccine Series
Additional Resource Links:
Infants Born To Mothers Who Have Hepatitis B: Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
Protecting Your Baby
Infants born to women with hepatitis B must receive accurate doses of hepatitis B vaccine and hepatitis B immune globulin to ensure complete protection. In order to protect these infants, medications should be given immediately after birth in the delivery room or within the first 12-24 hours of life*.
* See Testing and Treatment During Pregnancy section for details. Please note that testing of all pregnant women for hepatitis B is a global recommendation.
3-Dose Vaccine Series for Infants
The World Health Organization recommends that infants born to hepatitis B positive mothers receive the first dose of the hepatitis B vaccine within 24 hours of birth, and ideally a dose of hepatitis B immunoglobulin . These shots must be followed by the additional vaccine doses given on the recommended schedule. In the U.S., infants should follow a 1 month and 6-month schedule for the additional two doses.
4-Dose Combination Vaccine Series for Infants
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Are Hepatitis B Virus Infections Easily Avoided
Large quantities of hepatitis B virus are present in the blood of people with hepatitis B in fact, as many as one billion infectious viruses can be found in a milliliter of blood from an infected individual. Therefore, hepatitis B virus is transmitted in the blood of infected individuals during activities that could result in exposure to blood, such as intravenous drug use, tattooing, or sex with people who are infected. However, it is also possible to catch hepatitis B virus through more casual contact, such as sharing washcloths, toothbrushes or razors. In each of these cases, unseen amounts of blood can contain enough viral particles to cause infection. In addition, because many people who are infected don’t know that they are infected, it is very hard to avoid the chance of getting infected with hepatitis B virus.
Hepatitis B Vaccine: Canadian Immunization Guide
For health professionals
Last partial content update : May 2022
The footnotes in and the accompanying text description for the figure have been revised to align with the corresponding figure in Protocole d’immunisation du Québec, 5e édition from which it was adapted.
Last complete chapter revision :
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What Are My Next Steps Once I Get My Results
It can be difficult to understand what the results of your test mean. A healthcare provider can help you interpret your results and decide whether you need to take further action:
- If your results suggest that youre already immune to hepatitis B and arent contagious, you likely wont need to do anything.
- If your results suggest that youre not immune, a doctor may recommend vaccination, especially if youre somebody whos at a high risk of infection.
You may also need additional testing if more information is needed to interpret your results.
Appendix 1 Inclusionexclusion Criteria
| Criteria | ||
| Has the trial assessed anamnestic immune response to booster dose? | Yes | |
| Have the participants been randomised to booster hepatitis B vaccination versus placebo or no vaccination? | Yes | |
| Were they apparently healthy participants, with intact immune status, without previous hepatitis B virus infection? | Yes | |
| Were they free of predisposing factors for immunodeficiency? | Yes | No |
| Were they screened for serologic markers of hepatitis B virus infection before admission into the trial? | Yes | No |
| Have the participants already received either a 3dose or a 4dose schedule of hepatitis B vaccine? | Yes | |
| Was their vaccination history clear and reliable? | Yes | |
| Did they receive a monovalent hepatitis B vaccine not in fixed combination with other vaccines? | Yes | |
| Did they receive hepatitis B vaccine without immunoglobulin? | Yes | No |
| Types of interventions | ||
| Was the administered booster dose a monovalent vaccine of either recombinant vaccine or plasma derived vaccine ? | Yes | |
| Was the anamnestic immune response to booster dose of hepatitis B vaccine versus placebo investigated? | Yes |
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The Immunogenicity And Persistence Of Booster Dose With Hepatitis B Vaccine In College Students
| The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| Recruitment Status : Not yet recruitingFirst Posted : October 29, 2021Last Update Posted : December 6, 2021 |
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.
This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose , two-dose , or three-dose was given according to the antibody production level after booster vaccination among college students.
| Biological: 20 µg dose hepatitis B vaccine | Phase 4 |
Concurrent Administration Of Vaccines
HB-containing vaccines may be administered concomitantly with other vaccines or with HBIg. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.
Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.
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Data Collection And Analysis
Both review authors decided if the identified studies met the inclusion criteria or not. Primary outcomes included the proportion of participants with anamnestic immune response in nonprotected participants and signs of HBV infection. Secondary outcomes were the proportion of participants that developed local and systemic adverse events following a booster dose injection. We planned to report the weighted proportion with 95% confidence intervals .
Hepatitis B Vaccine Side Effects
The hepatitis B vaccine is considered a very safe and effective vaccine. Its made with an inactivated virus, so most types of the vaccine are even safe for pregnant people.
The hepatitis B vaccine may cause some mild side effects. The most common symptom is redness, swelling, or soreness where the injection was given. Some people also experience headache or fever. These effects usually last a day or two .
Rarely, some people have a serious and potentially life threatening allergic reaction to the vaccine. Call 911 or get to a hospital immediately if you experience any of the following symptoms after vaccination:
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Active Vaccination To Prevent Infection
Hepatitis B vaccination is available for preexposure and postexposure prophylaxis and provides long-term protection. Hepatitis B vaccines are produced recombinantly in yeast cell systems. The vaccines contain noninfectious HBsAg , a small amount of yeast protein, and aluminum hydroxide as an adjuvant. Pediatric formulations contain trace or no thimerosal. Administration is via the intramuscular route. Adverse effects are generally mild and mainly consist of local tenderness and low-grade fever. After a vaccine series, more than 95% seroconversion is achieved, which results in > 90% efficacy. Studies are ongoing to determine length of immunity, but it is at least 20 years.
Two hepatitis B single antigen vaccines are available in the United States: Recombivax from Merck & Co. and Engerix-B from GlaxoSmithKline. Both vaccines come in doses for pediatric and adult populations. High-dose vaccines are available for adult hemodialysis and immunocompromised patients. Both vaccines are given in a three-dose series and are generally interchangeable. A fourth dose may be given if a birth dose was administered. The birth dose must be a single antigen formulation.
Booster doses of hepatitis B vaccine beyond the initial series are generally not recommended. The long incubation period of hepatitis B theoretically allows for the development of a protective anamnestic immune response after exposure.
Fabrizio Fabrizi MD, … Paul Martin MD, in, 2017
Polymerase Chain Reaction Direct Sequencing And Hbv Genotyping
As previously described , HBV DNA was extracted by the Abbott m2000sp system, and then the S region of the HBV genome was amplified by PCR. The PCR products were sequenced, and the sequences were analysed by Mega 6.0 and BLAST . HBV genotyping was performed by a nPCR method previously established in our laboratory .
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How Is The Hepatitis B Vaccine Made
People are protected against hepatitis B virus infection by making an immune response to a protein that sits on the surface of the virus. When hepatitis B virus grows in the liver, an excess amount of this surface protein is made. The hepatitis B vaccine is made by taking the part of the virus that makes surface protein and putting it into yeast cells. The yeast cells then produce many copies of the protein that are subsequently used to make the vaccine. When the surface protein is given to children in the vaccine, their immune systems make an immune response that provides protection against infection with the hepatitis B virus.
The first hepatitis B vaccine was made in the 1980s by taking blood from people infected with hepatitis B virus and separating or purifying the surface protein from the infectious virus. Because blood was used, there was a risk of contaminating the vaccine with other viruses that might be found in blood, such as HIV. Although contamination with HIV was a theoretical risk of the early, blood-derived hepatitis B vaccine, no one ever got HIV from the hepatitis B vaccine. That is because the blood used to make vaccine was submitted to a series of chemical treatments that inactivated any possible contaminating viruses. Today, there is no risk of contaminating the vaccine with other viruses because the surface protein is manufactured in the laboratory.
A Note About Sex And Gender
Sex and gender exist on spectrums. This article will use the terms, male, female, or both to refer to sex assigned at birth. .
It is important that infants who are born to females with hepatitis B receive accurate doses of the hepatitis B vaccine. They may also be required to receive hepatitis B immunoglobulin if it is available.
The WHO also recommends using antiviral prophylaxis to help prevent hepatitis B transmission.
The table below outlines the two recommended hepatitis B vaccine schedules for infants born to those who have hepatitis B:
| Vaccine series |
|---|
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Us Children And Adult Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
3-Dose Vaccine Series for Children and Adults
The hepatitis B vaccine is an injection that is generally given in the arm as a three-dose series on a 0, 1, and 6-month schedule. Alternative schedules may be considered, noting that a third dose at 6 months, meeting minimum intervals between doses, is needed for maximum, long-term protection. Completing the hepatitis B vaccine series, preferably beginning at birth, will ensure protection against hepatitis B, hepatitis delta and lower the lifetime risk of liver cancer. Greater than 90% of babies and up to 50% of young children who are not vaccinated and are infected with hepatitis B will have lifelong infection, which makes the birth dose essential to their protection.
There are four, 3-dose vaccine brands approved in the U.S.
- PreHevbrio PreHevbrio is only approved for adults age 18 and over.
2-Dose Vaccine Series
Do The Benefits Of The Hepatitis B Vaccine Outweigh Its Risks
Every year in the United States about 2,000 people die following an overwhelming hepatitis B virus infection. In addition, every year about 22,000 people are infected with hepatitis B. Some of them will remain chronically infected, putting them at high risk of the long-term consequences of hepatitis B virus infection: cirrhosis and liver cancer. In fact, with the exception of influenza and COVID-19 viruses, hepatitis B virus causes more severe disease and death in the United States than any other vaccine-preventable disease. On the other hand, the hepatitis B vaccine is an extremely rare cause of a severe allergic reaction called anaphylaxis. To date, no one has died from this reaction, but it is theoretically possible that this could occur.
Because hepatitis B virus is a common cause of severe disease and death in the United States, and because the hepatitis B vaccine does not cause permanent damage or death, the benefits of the hepatitis B vaccine clearly outweigh its risks.
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I Am A Healthcare Worker Who Did Not Develop Hepatitis B Antibodies After Immunization What Should I Do
Two versions of hepatitis B vaccine are available. One, called Heplisav-B, contains a novel adjuvant that was not present in previous versions used by adults . Some people did not respond to the older version hepatitis B vaccine. In fact, in a group of adults younger than 40 years of age who received two doses of the older version vaccine 75 of 100 were protected. Following the third dose, this number increased to 90 of 100. However, people older than 40 years of age were less likely to respond to the vaccine with increasing age. On the other hand, 90 to 100 of 100 adults 18 years of age and older respond to Heplisav-B, which was approved for use in 2018.
About 5-10 of every 100 children and adults younger than 40 years of age do not respond to the third dose of the hepatitis B vaccine. Some of these people will be recommended to get vaccinated again. About 5 of 100 people will still not respond after getting all recommended doses of both series. Note that children younger than 18 years of age cannot get Heplisav-B.
If the people who do not respond to vaccination are determined not to have chronic hepatitis B, they will be reliant on taking precautions to reduce the chance of exposure and relying on those around them for protection. In other words, these people will be reliant on herd immunity.
Hepatitis B Status Of The Whole Cohort Of New Medical And Nursing School Entrants
Altogether, 414 students received pre-vaccination check . Of these, 162 were medical and 252 were nursing students of age 1733 years, and with a female to male ratio of 2.0 to 1. Seven students aged 1929 years, 2 females and 5 males, were found to be carriers . Six of them were borne from HBsAg-positive mothers. Among the 4 carriers born in mainland China, 1 reported a history of vaccination in infancy. Of the 3 other carriers born in Hong Kong, 2 were born after the adoption of universal neonatal immunization, but the students were not certain about their vaccination history.
Summary of participant deposition, characteristics and hepatitis B status.
Whole cohort of new medical and nursing school entrants. Cohort born after adoption of universal neonatal immunization.
The overall positive rate for anti-HBs was 30.4% . Altogether, 67.9% students negative for both HBsAg and anti-HBs, and all of them received 3 doses of HBV vaccine.
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