Hepatitis B – Global Health Press

Tradename	Manufacturer	License	Vaccine type	Handling	Indication	Schedule(s)	Dosage	Reactogenicity	Safety	Warnings	Contraindication	Co-administration	Immunogenicity	Seroprotection rate	Antibody persistence	Efficacy	Effectiveness	Storage	Shelflife	VacciTUTOR	Literature
ENGERIX-B	GlaxoSmithKline Biologicals s.a.	EMA	Hepatitis B vaccine (recombinant protein; expressed in yeast)	0.5 mL single pediatric dose vials or prefilled syringes, 1.0 mL adult dose vials or prefilled syringes	Active immunizing agent against infection caused by all known subtypes of hepatitis B virus			Check "Vaccines summary"	check "Vaccines Summary"	The tip caps of the syringes contain natural rubber latex which may cause allergic reactions. Temporarily defer vaccination of infants with a birth weight less than 2,000 g born to hepatitis B surface antigen (HBsAg)-negative mothers.	Check "Vaccines summary"	with HPV vaccine CERVARIX, immune globulin, BCG, DTP, DT and/or polio vaccines, MMR, Hib and hepatitis A vaccines.	see below	Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.1 Seroconversion is defined as antibody titers ≥1 mIU/mL.			No data	2°C – 8°C	3 years	Chapter 37
RECOMBIVAX HB®	Merck	FDA	HBsAg recombinant protein expressed in yeast	RECOMBIVAX HB is available in single-dose vials and prefilled Luer-Lok® syringes. RECOMBIVAX HB DIALYSIS FORMULATION is available in single-dose vials	prevention of infection caused by all known subtypes of hepatitis B virus			Check "Vaccines summary"	check "Vaccines Summary"	Hypersensitivity to Latex; Apnea in Premature Infants <2000 g (vaccination should be delayed until 1 month of age)	Check "Vaccines summary"	with DTwP; OPV; MMR; eIPV; VARIVAX®; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of DTaP may be administered concomitantly with HBIG. The first dose of RECOMBIVAX HB may be given at the same time as HBIG, but the injections should be administered at different sites.		see below			No data	2-8°C , protect from light	3 years	Chapter 37	Link
HEPLISAV B	Dynavax	EMA	recombinant HBsAg protein, CPG-adjuvanted	Solution for injection in pre-filled syringe.	prevention of infection caused by all known subtypes of hepatitis B virus	approved for use in adults >18 years of age; 2 doses 1 month apart	One dose (0.5 ml) contains: HBsAg 20 µg adjuvanted with 3000 µg CpG 1018, a 22-mer oligonucleotide comprising microbial DNA-like unmethylated CpG motifs; produced in yeast (Hansenula polymorpha) by recombinant DNA technology	Check "Vaccines summary"	Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed.	HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. ICH may have a diminished immune response to HEPLISAV-B.	Check "Vaccines summary"	No data, co-administration is not recommended. Concomitant administration of HEPLISAV B with hepatitis B immunoglobulin (HBIG) has not been studied.	Based on seroprotection rate - below	Protective immunity (anti-HBsAg ≥ 10 mIU/mL) achieved in 95% adults 18-55 years after full course of vaccination; and in 90% of adults 40 - 70 Years		Clinical trials indicate higher seroprotection rate than non-adjuvanted product.	No data	2°C to 8°C	3 years		Link
PREHEVBRIO	VBI Vaccines (Delaware) Inc	FDA	Hepatitis B vaccine (recombinant HBsAg)	package of 10 single dose vials	Prevention of hepatitis B	≥ 18 years: three doses at 0-, 1- and 6-months	10 µg recombinant hepatitis B surface antigens (pre-S1, pre-S2, and S) adsorbed on aluminum hydroxide adjuvant (0.5 mg/mL)	Check "Vaccines summary". For rare side effects check product profile.	check "Vaccines Summary"	do not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infrvtion, ICH may have reduced immune response.	Check "Vaccines summary"	NA	was evaluated in comparison with a US-licensed hepatitis B vaccine (Engerix-B).	anti-HBs titers ≥ 10 mIU/mL	NA	91.4 (89.1, 93.3) (evaluated in comparison with Engerix SPRs)	NA	2°C to 8°C . Protect from light.	36 months
Infanrix hexa	GSK	EMA FDA	DTaP-HBV-IPV- Hib vacccine (adsorbed)	pre-filled syringe	ctive immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday )	see locally recommended schedule for infants immunization		Check "Vaccines summary"	Seventeen years of post-licensure experience confirm confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers.	If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give INFANRIX should be based on potential benefits and risks.For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with INFANRIX	Encephalopathy within 7 days of administration of a previous pertussis- containing vaccine. Progressive neurologic disorders. Allergy to neomycin.	Second dose MMR vaccine	VERO cell toxin-neutralizing test: diphtheria antitoxin concentration >0.01 IU/mL. In vivo mouse neutralization assay: tetanus antitoxin concentration >0.01 IU/mL			Pertussis vaccine efficacy (with DTaP) against >14 days of any cough or against paroxysmal cough was 73% (95% CI: 59, 82) and 84% (95% CI: 71, 91), respectively; "seroprotection" rates used for other vaccine components.	see data on individual vaccine components	2°C to 8°C	24 months	Chapter 28	Link
Vaxelis	Sanofi	EMA	Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (recombinant), poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine (adsorbed).	pre-filled syringe	primary and booster vaccination of infants and toddlers from age > 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib)	two or three doses, >1 month apart as of 6 weeks of age. If a birth dose of hepatitis B vaccine was given, Vaxelis can be used for later doses of hepatitis B vaccine as of age >6 weeks. If a 2nd dose of hepatitis B vaccine is recommeneded before this age, monovalent hepatitis B vaccine should be used. Booster vaccination: After a 2-dose or a 3-dose series, booster needed at least 6 months after last dose.		Check "Vaccines summary". For rare side effects check product profile.	Check Vaccines Summmary	Caution needed in chilren with a history of fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine. Apnea following intramuscular vaccination observed in some infants born prematurely.	History of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized; a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause; history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.		Licence based on seroprotection achieved for the single components; see below		NA	see single components		2°C – 8°C	4 years	Chapter 28	Link
Pediarix	GSK	FDA, (EMA: no longer authorised)	D, T, aP vaccine adsorbed, hepatitis B (recombinant) and IPV	color-coded, single-dose prefilled syringes	active immunization against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis	3-dose series in infants of hepatitis B surface antigen (HBsAg)-negative mothers given > 6 weeks through 6 years of age. Total of 4 doses of hepatitis B vaccine permitted if hepatitis B combination vaccine is administered after the birth dose		Check "Vaccines summary"	In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines	Check "Vaccines summary"	The efficacy of the pertussis component of PEDIARIX, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX.	NO DATA	The immune responses to all vaccine components were evaluated in sera obtained 1 month (range: 20 to 60 days) after the 3rd dose of PEDIARIX or INFANRIX. Adjusted GMCs / seroprotection rates in the PEDIARIX group were non-inferior to separately administered vaccines			The efficacy of the pertussis component of PEDIARIX, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX		2°C and 8°C		Chapter 28	Link
Revac B	Bharat Biotech	WHO	Hepatitis-B (recombinant portein)	Suspension for injection in 05, 1 mL vials and pre-filled syringes	protects against hepatitks B, and in neonates, infants and young adults also from probable hepatitis B virus induced carrier state, cinrhosis and hepatic cellular carcinoma	Children: 1st dose at birth, 2nd dose 6 weeks of age, 3rd dose 14 weeks of age. Final dose administred < 24 weeks and > 16 weeks after 1st dose. Adults: Interval of 30 days between 1st and 2nd dose, followed by 3rd dose 180 days after first dose.	0.5 mL vial contain: HBsAG ≥10 µg; Al+++ 0.25 mg; Phosphate buffer saline q.s. to 0.5 mL. 1 mL vial contains: HBsAG≥ 20 µg; Al+++ 0.5 mg; Phosphate buffer saline q.s. to 1 mL	Check "Vaccines summary". For rare side effects check product profile.	Vaccines Summary	excerebration of multiple sclerosis has been reported	Hypersensitivity to vaccine components, severe febrile illness, multiple sclerosis, allergy to viral vaccines	Hib, BCG, polio, measles, mumps, rubella, diphteria, tetanus, influenza, pneumococcal vaccines (unlcear which). Should not be administred with HBIg.	see below	95.5%;		soley based on seroprtection, reach in clinical trials in 92% to 98% of recipients.		2°C to 8°C
Elovac-B	Indian Immunologicals Ltd	WHO?	Hepatitis-B (recombinant protein)	sterile suspension, ready to use for IM injections	prevention of infection hepatitis B	children < 15 years: 10 µg HBsAg 0.5mL suspension; >15 years: 20 µg HBsAg in 1mL suspension	0.5 mL vial contains: HBsAg ≥ 10 µg; Al+++ 0.25 mg; thiomersal 0.025 mg; phosphate buffer, saline q.s. to 0.5 mL. 1 mL vial contains: HBsAG ≥ 20 µg; Al+++ 0.5 mg;thiomersal 0.05 mg; Phosphate buffer, saline q.s. to 1 mL	Check "Vaccines summary". For rare side effects check product profile.	No specific safety concern.	The immune response may different by patient profile: age, smoking, obesity, ICH may have lower Ab titers.	Check "Vaccines summary".	with DPT, T, DT, OPV, MMR, Hib, HepA and BCG vaccines.	no data given	no data given		probably based on seroprotection rates		2 - 8°C		Chapter 37	Link