Hepatitis B Vaccine

Sayenna Uduman, Dr. M.I. Sahadulla, Dr. Raja Lakshmi, Dr. Abdul Kareem Uduman
Hepatitis B Vaccine - Treatment
Hep B Vaccine Recommendation in general & specific:
Recommended specifically for all infants and children; also for adults in high risk groups be vaccinated. Since every person is at some risk for infection, vaccination schedule & guidelines should be individualized for each situation. A regimen of 0 – 1 – 6 months schedule of immunization has been most widely used and proven to be ideal with protective anti-HBs antibody titers attained at the end of the 3-doses vaccination. This schedule prevents infections acquired during early childhood, adolescent and older, which accounts for most of the HBV- related disease burden at global level. However, this schedule does not prevent perinatal transmission of HBV infections because it does not include a dose of HepB vaccine at birth. In high endemic countries , where a high proportion of HBV infections are acquired perinatally, the first dose of HepB vaccine should be given as soon as possible (<24 hours) after birth. India has been designated by WHO as intermediate to high endemic for HepB infection.
• Universal immunization of infants beginning at birth prevents perinatal transmission of maternal infection to newborn and early childhood, which accounts for most of the HBV-related disease burden and
• The monovalent HepB vaccine should be used for birth dose or any doses administered before age 6 weeks. The HepB containing combination vaccines (there are many varieties of combo’s are available in the Indian pharmaceutical markets- see table 3) can be administered for the 2nd and 3rd doses.
• A 4- dose to be administered if a birth dose is given and a combo is used (at 1-2, 4, and 6 months) to complete the series.
• HepB vaccine is considered one of the safest and most effective vaccines ever made. The immunogenicity and long-term efficacy of newborn and infant immunization have been proven extensively.
• No booster dose vaccination is recommended for immunocompetent children and adults based on the findings of many from other long-term cohort studies with many decades of follow-up [ J Infect Dis. (2016) .First published online: January 21, 2016 http://jid.oxfordjournals.org/content/early/2016/01/21/infdis.jiv748.full ]
• HepB vaccine is a T-cell dependent vaccine and there is always a possibility of anamnestic immune response to subsequent exposure to virus again in future.
• There is no evidence of serious adverse events that have been causally linked except soreness and redness at the injection site.
• Vaccine administrations: Intramuscular injection in the anterolateral thigh for infants or deltoid region for children and adults. Do not give in the gluteal region & this has been associated with decreased immunogenicity. Intradermal route is not approved universally.

IAP recommended HBV Vaccines (2014):
A variety of schedules may be used for HepB immunization in national programs. (http://www.iapcoi.com/hp/pdf/9-%20HEPATITIS%20B%20VACCINE.pdf). The IAP recommends vaccine given to all children in any of the following schedules: (i) Birth, 1 and 6 months (ii) Birth, 6 and 14 weeks (iii) 6, 10 and 14 weeks (iv) Birth, 6 weeks, 6 months (v) Birth, 6 weeks,10 weeks, 14 weeks. Three doses are generally required to complete the immunization series, although there is an alternate two-dose accelerated vaccination schedule for adolescents Aged 11--15 Years.

Combination Vaccine Schedule:
In table 3, IAP authorized Combo’s containing HepB formulary is summarized;

Table 3: IAP approved HepB containing Combo’s are
Pentavac PFS
serum Institute of India
DTwP - rHepB / Hib Diphtheria Toxoid 20 Lf to 30 Lf , Tetanus Toxoid 2.5 Lf to 10 Lf, B. Pertussis 4 IU , HBsAg (rDNA) 10 mcg, capsular Hib PRP -Conjugated to Tetanus Toxid (carrier protien) 10 mcg, Adsorbed on Aluminium Phosphate, AL 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection.
DTwP - rHepB / Hib Fully liquid combination of DTwP, HepB (10mcg) and hib conjugated with CRM197. 0.5ml pediatric dose.
DTwP: Diphtheria, Tetanus, whole cell pertussis vaccine. Hib- hemophilus influenzae type b

Over the past several years either DTaP or DTwP based HepB containing combos has been incorporated in childhood immunization program at regional and national (NIP) level. The list of WHO pre-qualified HepB containing combo formularies are numerous and available for developing countries through the UNICEF support. Decision to incorporate combo’s containing HepB component in the national EPI schedules may result in administering 4- doses, which is acceptable. Table 4 summarizes, an illustrative example of HepB based combo’s schedules that are incorporated in childhood immunization since 2009 in a nearby Middle-East country (Abu Dhabi Health Authority, UAE - Immunization schedule).

Table 4. Childhood (Combo’s) Immunization schedule – Health Authority, Abu Dhabi 2015 -2016
Age Vaccine given
Birth dose HepB1, BCG
2nd month end Hexavalent* ( DTaP, HepB2 IPV & Hib ) , PCV13, RV1( RV monovalent vaccine)
4th month end Hexavalent* ( DTaP, HepB3 IPV & Hib ), PCV13 , OPV1, RV2( RV monovalent vaccine )
6th month end Pentavalent *( DTaP, HepB4 & Hib) OPV , PCV13
12th month end MMR1, Varicella1
18th month end Tetravalent* ( DTaP , Hib ), Pcv13, OPV , MMR
*Hexavalent: Sanofi-Pasteur; Pentavalent: Arab pharmaceutical; Tetravalent: Sanofi-Pasteur.

HepB Immunization Strategies:
A wide-ranging immunization strategy to eliminate HBV transmission has been employed progressively at global level, focusing primarily on the following aspects;

1. Routine immunization (standard 3 doses regime) of children and adolescents who previously have not been immunized; However, this schedule does not prevent perinatal HBV infections because it does not include a dose of HepB vaccine at birth.
• Infants who did not receive a birth dose should receive 3 doses on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible.
• Catch-up vaccination: Unvaccinated persons should complete a 3-dose series.
• A 2-dose series (doses separated by at least 4 months) of adult formulation. Recombivax HB is licensed for use in children aged 11 through 15 years.
Duration of protection among children and adolescents who have received the recombinant HepB vaccination series is known to be long. Less is known about duration of protection of the vaccination series after being administered during infancy.

2. Universal immunization of infants soon after birth (HepB birth dose);
This schedule prevents perinatal transmission of maternal infection to newborn and early childhood, which accounts for most of the HBV-related disease burden in countries with high endemicity. Also, administering the vaccine earlier in life makes it easier to achieve high immunization coverage.
• Birth dose, a monovalent HepB vaccine is given to all newborns before hospital discharge.
• The second dose should be administered at age 1 to 2 months ; a minimum interval of 4 weeks , and
• The 3rd dose at 6 months of age, at least 8 weeks after the second dose & at least 16 weeks after the first dose.
The monovalent vaccine should be used for birth dose or any HepB doses administered before age 6 weeks. The HepB containing combination vaccines can be administered for the 2nd and 3rd doses. Administration of a total of 4 doses is permitted when a combination vaccine containing HepB is administered after the birth dose.

3. Prevention of perinatal HBV infection through routine screening of all pregnant women and appropriate immunoprophylaxis of infants born to HBsAg-positive women and infants born to women with unknown HBsAg status;
• Infants at greatest risk of infection were those born to women who were younger, HB e-antigen positive, or who had a high viral load or those infants who received less than 3 HepB vaccine doses.
• Infants born to HBsAg-positive mothers, administer vaccine and 0.5 mL of HBIG within 12 hours of birth. These infants should be tested for HBsAg and antibody to HBsAg (anti-HBs) 1 to 2 months after completion of the vaccine series at age 9 through 18 months (preferably at the next well-child visit).
• If mother’s HBsAg status is unknown, within 12 hours of birth administer HepB vaccine regardless of birth weight. For infants weighing less than 2,000 grams, administer HBIG in addition to HepB vaccine within 12 hours of birth. Determine mother’s HBsAg status as soon as possible and, if mother is HBsAg-positive, also administer HBIG for infants weighing 2,000 grams or more as soon as possible, but no later than age 7 days.

4. Immunization of previously unimmunized adults at increased risk of infection.
Should vaccinate any person seeking protection from HBV infection and persons with any of the following indications:
• Persons with end-stage renal disease (including patients receiving hemodialysis), persons with HIV infection, and persons with chronic liver disease;
• Health care personnel who are potentially exposed to blood or other infectious body fluids;
• Household contacts and sex partners of HB sAg -positive persons and staff members of institutions for persons with developmental disabilities
• Diabetic patients : at the discretion of the treating clinician based on the likelihood of acquiring infection, including the risk posed by an increased need for assisted blood Glucose monitoring
• Persons seeking evaluation or treatment for a sexually transmitted disease (STD); current or recent injection drug users; and men who have sex with men;

Dosing schedules in adults & at high risk:
• Administer missing doses to complete a 3-dose series to those persons not vaccinated or not completely vaccinated.
• If the combined hepatitis A and Hepatitis B Vaccine (Twinrix) is used, give 3 doses at 0, 1, and 6 months; alternatively, a 4-dose Twinrix schedule may be used, administered on days 0, 7, and 21–30, followed by a booster dose at 12 months.
• Adult patients receiving hemodialysis or with other immunocompromising conditions should receive 1 dose of 40 mcg/mL (Recombivax HB) administered on a 3-dose schedule at 0, 1, and 6 months or 2 doses of 20 mcg/mL (Engerix-B) administered simultaneously on a 4-dose schedule at 0, 1, 2, and 6 months.

5. Immunization during Pregnancy or Lactation is not contraindication to vaccination because acute HBV infection may result in severe disease in the mother and chronic infection in the newborn infant.

Pre and Post vaccination serologic testing aspects:
The individual clinician is in the best position to determine which tests are most appropriate for a particular patient.
Pre vaccination sero-susceptible testing is NOT INDICATED routinely for children or adolescents. Post vaccination Serologic Testing (PVST) for anti-HBs is NOT NECESSARY after routine vaccination of healthy people but is recommended 1 to 2 months after the third or 4th vaccine dose for the following specific groups:
• Infants born to sAg-positive mothers should be tested for sAg and antibody (anti-HBs) titer, 1 to 2 months after completion of the vaccine series at age 9 through 18 months
Also, the PVST for anti-HBs is recommended for the following specific groups of individuals namely; a) hemodialysis patients – should test antibody level annually b) chemotherapy receiving immunocompromised patients including , hematopoietic stem-cell transplant recipients, c) people with HIV infection d) persons at occupational risk of exposure from percutaneous injuries or mucosal or non-intact skin exposures and, etc.

Management of vaccine non-responders; those who do not develop a serum anti-HBs response (10 mIU/mL or greater) after a primary vaccine series should be tested for HBsAg to rule out the possibility of a chronic infection as an explanation of failure to respond to the vaccine. If the HBsAg test result is negative, an additional 3-dose series should be administered. Those who remain anti-HBs negative 1 to 2 months after a re-immunization series are unlikely to respond to additional doses of vaccine and should be considered nonimmune

To conclude, newborn and infant HepB vaccination programs should become an integral part of national immunization schedules worldwide. A variety of schedules may be used for HepB immunization in national programs, depending on the local clinical burden, parental immunization attitude and regional epidemiological situations. High coverage with the primary vaccine series among infants has the greatest overall impact on the prevalence of chronic HBV infection and its serious consequences including liver cirrhosis and hepatocellular cancer. It is very vital and crucial for health care professionals to work together closely at the national and regional Health Ministry levels to maximize the impact of hepatitis control activities.

Hepatitis B Vaccine Hepatitis B Vaccine 05/22/2016
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