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Route
IM
Administration
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| bet | 270/654 | | Sana | 03.01.2022 | | Hajmi | 1,5 Mb. | | #14803 |
Route
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IM
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Administration
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IM injection. Shake well before use.
Give at a separate site from other concurrently administered vaccines/IM injections.
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Monitoring
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-HBsAgs and hepatitis B surface antibodies should be measured in infants born to mothers with
chronic HBV 3-12 months after completing the primary vaccine course
-Potential risk of apnoea in preterm infants particularly <28 weeks of gestation when administering primary immunisation series. Monitor cardiorespiratory status for 48-72 h post administration
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Contraindications
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Serious allergic reaction (e.g. anaphylaxis) after previous vaccine dose or to a component of vaccine,
including yeast.
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Adverse Reactions
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-Soreness at the injection site is common
-Fever greater than 37.7 degree C occurs in 1%-6%
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Storage
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Store between 2 and 8°C. Do NOT freeze as this reduces potency. Storage above or below the recommended temperature may decrease potency.
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- Postpone vaccination in significant acute illness or fever >38.5 degrees C
-IM injections should not be given if there is severe thrombocytopenia or a coagulation disorder like haemophilia
- Use caution in latex sensitive individuals as tip caps of the pre-filled syringes may contain natural rubber latex
- Efficacy of the HBV vaccine is measured by its ability to induce hepatitis B surface antibody (Hbs Ab) at a titre of >10 IU/L.3
- In healthy infants, 30%-40% protection against HBV infection is achieved with one dose of the
vaccine, 50%-75% protection with two doses and >90% with three doses.3
- Booster doses are not currently recommended for fully vaccinated, immunocompetent individuals
- Preterm neonates <2000 g or <32 weeks do not respond as well to hepatitis B vaccine as full term babies. They should have the usual dosing schedule and then consider a booster dose at 12months1
- All newborns born to HBsAg-positive mothers, must receive both a birth dose of hepatitis B vaccine and hepatitis B immune globulin (HBIG) in separate thighs preferably within 12 h of birth. This regimen results in the seroconversion rates of 96%.4
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Evidence summary
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- van den Ende et al. [29] performed a systematic review on immunogenicity of Engerix B (GSK HepB, GSK, Belgium) vaccine in children. They found that primary 3-dose vaccination of healthy infants and children, including infants born to HBsAg-positive mothers, using the standard 0, 1, 6 month schedule was associated with seroprotection rates >= 96.0%. Children with severe underlying disease, including human immunodeficiency virus infection and cancer had lower seroprotection rates. The vaccine had a clinically acceptable safety profile in all the populations studied.
- Dolhain et al. [30] performed a systematic review of 6 clinical trials conducted in the South-East
Asia and Western Pacific Regions, investigating vaccination regimens with >3 doses of HBV containing vaccines in infants, including a monovalent HBV vaccine birth dose and >=1 dose of
Infanrix Hexa (GSK's hexavalent DTPa-HBV-IPV/Hib vaccine). They found in all studies, three primary doses of hexavalent DTPa-HBV-IPV/Hib vaccine administered during the first 6 months of life, which induced a robust immune response to all vaccine antigens and had a clinically acceptable safety profile.
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References
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1. The Australian Immunisation Handbook. https://immunisationhandbook.health.gov.au/about-the-handbook. Accessed 21-12-2020
2. MIMS Australia, Hepatitis B Immunoglobulin-VF full product information (Accessed 21-12-2020).
3. Demirjian A, Levy O. Safety and efficacy of neonatal vaccination. Eur J Immunol. 2009;39(1):36-46. doi:10.1002/eji.200838620
4. Lee C, Gong Y, Brok J, et al. Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers. Cochrane Database Syst Rev 2006; :CD004790.
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Original version Date: 8/08/2015
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Author: NMF Consensus Group/TC
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Current Version number: 2
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Current Version Date: 21/12/2020
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Risk Rating: Low
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Due for Review: 21/12/2025
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Approval by: DTC
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Approval Date: TBA
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