Hepatitis B (rDNA) 5micrograms/0.5ml vaccine suspension for injection vials
Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix.
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HBvaxPRO 5micrograms/0.5ml vaccine suspension for injection vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(5)
Hepatitis B and C testing: people at risk of infection (PH43)
Drug use disorders in adults (QS23)
Hepatitis B (chronic): diagnosis and management (CG165)
Hepatitis B (QS65)
Reducing sexually transmitted infections (NG221)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 15 · Randomised trials: 13 · 1981–2026
Showing the 50 most relevant studies, sorted by most relevant.
S. Schillie, A. Harris, Ruth Link-Gelles, et al.
Morbidity and Mortality Weekly Report, 2018
Shigui Yang, Guo Tian, Yuanxia Cui, et al.
Scientific Reports, 2016
D. Fisman, D. Agrawal, K. Leder
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2002
M. Fonseca, L. Pang, Norma de Paula Cavalheiro, et al.
Vaccine, 2005
O. Launay, D. van der Vliet, A. Rosenberg, et al.
JAMA, 2011
Muwanda F, Sendagire H, Mboowa G, et al.
2023
- Hepatitis B
- Hepatitis B Vaccines
- Hepatitis B virus
Childhood HBV immunization remains globally fundamental to the elimination of hepatitis B virus (HBV). However, monitoring proportions of HBV vaccine seroprotection and their determinants among African Pediatric recipients is crucial. This study sought to verify extent of immune protection accorded by the HBV vaccine in African children of up to 17 years of age by pooling the prevalence of seroprotection reported by primary studies conducted in the Northern, Western, and Southern African regions. We included 19 eligible articles out of the 197 initially downloaded, published from 1999 to 2021 from African Journals Online (AJOL), EMBASE, Scopus, and PubMed. The study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO), University of York Centre for Reviews and Dissemination, under the registration number CRD42022361277. Significantly higher (p < 0.0001) proportion of HBV vaccine seroprotection (69.07%) was found among children under 15 years of age than children 15-17 years (32.368%), 95% CI [34.2454-39.0847%]. Whereas successful integration of the HBV vaccine on the extended programs on immunizations (EPI) has been a major achievement in the reduction of HBV infection in Africa, markedly reduced HBV vaccine seroprotection is persistently demonstrated among adolescent children 15-17 years of age. Future studies are required to clarify the need for booster dose vaccination in most at risk populations and age groups.
Abstract licence: CC BY
Geta M, Yizengaw E, Manyazewal T
2024
- Hepatitis B
- Hepatitis B Vaccines
- Hepatitis B virus
BackgroundGlobally, 257 million people have chronic hepatitis. Even though a safe and effective prophylactic vaccine against HBV infection has been available, it causes significant morbidity and mortality. HBV vaccines were designed to improve or modulate the host immune responses. The effectiveness of the vaccine is determined by measuring serum hepatitis B surface antibody (Anti-HBs) level. Therefore, this systematic review aimed to evaluate the effectiveness of hepatitis B vaccine among vaccinated children.MethodsPreferred reporting items for systematic review and meta-analysis (PRISMA) guidelines was applied for systematically searching of different databases. Only cross-section studies measuring the level of anti-HBs of vaccinated children were included. The seroprotective level with anti-HBs > 10mIU/ml was extracted. The meta-analysis was performed using statistical software for data sciences (STATA) version 14. Effectiveness estimates were reported as a proportion of anti-HBs level. The heterogeneity between studies was evaluated using the I2 test, and I2 > 50% and/or P ResultsA pooled sample size of the included papers for meta-analysis was 7430. The pooled prevalence of seroprotected children was 56.95%, with a heterogeneity index (I2) of 99.4% (P 100mIU/ml). Based on subgroup analysis using country of studies conducted, the highest prevalence of anti-HBs was 87.00% (95% CI: 84.56, 89.44), in South Africa, and the lowest was 51.99% (95% CI: 20.41-83.58), with a heterogeneity index I2 = 70.7% (p = 0.009) in Ethiopia.Conclusion and recommendationsHepatitis B vaccine seroprotective level in the current pooled analysis have suboptimal, which failed to demonstrate consistent effectiveness for global hepatitis B virus elimination plan in 2030. Using consistent age group may have a significant value for the decision of the HB vaccine effectiveness. A significant heterogeneity was observed both in studies conducted in Ethiopia and Egypt. Therefore, the impact of HB vaccination on the prevention of hepatitis B virus infection should be assessed regularly in those countries. Future meta-analysis is needed to investigate all possible vaccines in a separate way of reviewing, which will lead to a strong conclusion and recommendations.
Abstract licence: CC BY
Abhinav Sinha, Gayatree Nanda, Rounik Talukdar, et al.
Public Health Reviews, 2026
Zadeh Mehrizi T, Eshrati B, Ebrahimi Shahmabadi H
2025
- Hepatitis B virus
- Hepatitis B
- Hepatitis B Vaccines
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
Not available
Mechanism
ENGERIX®-B induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
Half-life
Protein binding
Volume of distribution
Metabolism
Elimination
Clearance
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The hepatitis B virus induces a severe form of viral hepatitis. Other causative agents are hepatitis A virus, and the non-A, non-B hepatitis viruses. Hepatitis D virus, a defective virus requiring the “keeper function” of the hepatitis B virus, occurs either as a co-infection or super-infection in a HBsAg carrier.
Transmission of the virus occurs through percutaneous contact with contaminated blood, serum or plasma. Infection may also occur by the exposure of mucous surfaces, or intact or damaged skin to other body fluids such as saliva, mucosal secretions and semen.
There is no specific treatment for hepatitis. The incubation period may be as long as 6 months, followed by a very complex clinical course of an acute or chronic nature, often leading to hospitalization.
Viral hepatitis caused by hepatitis B virus is a major worldwide health problem, though the incidence and epidemiology vary widely among geographical areas and population subgroups.
In Canada, the United States and Northern Europe, 4% to 6% of the population are infected during their lifetime (mostly young adults); between 5% and 10% of infections lead to persistent viremia (carrier state). Certain population subgroups in these areas, however, are at high risk (see Indications and Clinical Use).
In Asia, infection often occurs early in life, leading to a hepatitis B marker prevalence of more than 70% in the general population and a carrier rate of up to 20%.
It is estimated that the reservoir of persistent hepatitis B surface antigen carriers amounts to 350 million people worldwide. Carriers are at a high risk of developing chronic liver disease which may lead to cirrhosis or primary hepatocellular carcinoma. A significant reduction in the incidence of hepatocellular carcinoma has been observed in children aged 6 to14 years following a nationwide hepatitis B vaccination in Taiwan. This resulted from a significant decline in the prevalence of hepatitis B antigen, the persistence of which is an essential factor in the development of hepatocellular carcinoma.
Vaccination against hepatitis B is expected in the long term to reduce the overall incidence of both hepatitis B and the chronic complications such as chronic active hepatitis and cirrhosis.
The vaccine will not protect against infection caused by hepatitis A and non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection or carrier state, it can be expected that hepatitis D will also be prevented by vaccination with hepatitis B virus vaccine.
The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose.
It may also be used to complete a primary course of vaccination started with plasma-derived or yeast-derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived or yeast-derived vaccines.
In areas of low prevalence of hepatitis B, vaccination is strongly recommended in subjects who are at increased risk of infection. These include the following groups:
* Health professionals: physicians and surgeons; oral surgeons and dentists; nurses, dental nurses, dental hygienists, podiatrists; IV teams and operating room personnel; paramedical personnel in close contact with patients; staff in hemodialysis, nephrology, hepatology, hematology and oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; pathologists and morgue attendants; cleaning staff who handle waste in hospitals; emergency and first aid workers; ambulance staff; dental, medical and nursing students.
* Patients: patients receiving frequent blood transfusion or clotting factor concentrates, such as those in oncology units and those with thalassemia, sickle-cell anemia, cirrhosis, hemophilia, etc.; patients on hemodialysis; patients with type 2 diabetes.
* Personnel and residents of institutions: persons with frequent and/or close contacts with high-risk groups; prisoners and prison staff; residents and staff of institutions for the developmentally challenged (those who are in contact with aggressive biting residents being at highest risk).
* Persons at increased risk due to their sexual practices: males having sexual contact with other males; others with multiple sexual partners or with a recent history of sexually transmitted disease.
* Persons who use injectable drugs illicitly.
* Travellers to areas of high endemicity and their close contacts.
* Household contacts of any of the above groups and of patients with acute or chronic hepatitis B infection.
* Infants born of HBsAg-positive mothers.
* Chronic Liver Disease (CLD): subjects with chronic liver disease; subjects at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol).
* Others: police; fire fighters; armed forces personnel; morticians and embalmers; those who through their work or personal lifestyle may be exposed to the hepatitis B virus.
* In areas of both low and high prevalence, vaccination should be offered to all young children and neonates at risk, as well as to adult high risk groups.
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 287 interactions
primary vaccination schedule of ENGERIX®-B (hepatitis B vaccine (recombinant)).
How the body processes this drug — absorption, distribution, metabolism, and elimination
ATC J07CA08
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Hepatitis B Vaccine (Recombinant)
Matched from: Hepatitis B vaccine
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72