Vaccines:
Indications for: ENGERIX-B
Hepatitis B immunization.
Clinical Trials:
Efficacy in Neonates
- Protective efficacy with Engerix-B was demonstrated in a clinical trial in neonates at high risk of hepatitis B infection.
- Fifty-eight neonates born of mothers who were both HBsAg-positive and hepatitis B “e” antigen (HBeAg)-positive were given Engerix-B (10 mcg/0.5 mL) at 0, 1, and 2 months, without concomitant hepatitis B immune globulin (HBIG).
- Two infants became chronic carriers in the 12-month follow-up period after initial inoculation. Assuming an expected carrier rate of 70%, the protective efficacy rate against the chronic carrier state during the first 12 months of life was 95%.
Immunogenicity in Neonates
- In clinical studies, neonates were given Engerix-B (10 mcg/0.5 mL) at age 0, 1, and 6 months or at age 0, 1, and 2 months. The immune response to vaccination was evaluated in sera obtained 1 month after the third dose of Engerix-B.
- Among infants given Engerix-B at age 0, 1, and 6 months, 100% of evaluable subjects (n=52) seroconverted by Month 7. The geometric mean antibody titer (GMT) was 713 mIU/mL. Of these, 97% had seroprotective levels (≥10 mIU/mL).
- Among infants enrolled (n=381) to receive Engerix-B at age 0, 1, and 2 months, 96% had seroprotective levels (≥10 mIU/mL) by Month 4. The GMT among seroconverters (n=311) (antibody titer ≥1 mIU/mL) was 210 mIU/mL. A subset of these children received a fourth dose of Engerix-B at age 12 months. One month following this dose, seroconverters (n=126) had a GMT of 2941 mIU/mL.
Immunogenicity in Children and Adults
Persons Aged 6 Months through 10 Years
- In clinical trials, children (N=242) aged 6 months through 10 years were given Engerix-B (10 mcg/0.5 mL) at 0, 1, and 6 months. One to 2 months after the third dose, the seroprotection rate was 98% and the GMT of seroconverters was 4023 mIU/mL.
Persons Aged 5 through 16 Years
- In a separate clinical trial including both children and adolescents aged 5 through 16 years, Engerix-B (10 mcg/0.5 mL) was administered at 0, 1, and 6 months (n=181) or 0, 12, and 24 months (n=161). Immediately before the third dose of vaccine, seroprotection was achieved in 92.3% of patients vaccinated on the 0-, 1-, and 6-month schedule and 88.8% of patients on the 0-, 12-, and 24-month schedule (GMT: 118 mIU/mL vs 162 mIU/mL, respectively, P =0.18). One month following the third dose, seroprotection was achieved in 99.5% of children vaccinated on the 0-, 1-, and 6-month schedule compared with 98.1% of those on the 0-, 12-, and 24-month schedule. GMTs were higher (P =0.02) for children receiving vaccine on the 0-, 1-, and 6-month schedule compared with those on the 0-, 12-, and 24-month schedule (5687 mIU/mL vs 3159 mIU/mL, respectively).
Persons Aged 11 through 19 Years
- In clinical trials with healthy adolescent patients (aged 11 through 19 years), Engerix-B (10 mcg/0.5 mL) given at 0, 1, and 6 months produced a seroprotection rate of 97% at Month 8 (n=119) with a GMT of 1989 mIU/mL (n=118; 95% CI, 1318-3020). Immunization with Engerix-B (20 mcg/1 mL) at 0, 1, and 6 months produced a seroprotection rate of 99% at Month 8 (n=122) with a GMT of 7672 mIU/mL (n=122; 95% CI, 5248-10965).
Persons Aged 16 through 65 Years
- Clinical trials in healthy adult and adolescent patients (aged 16 through 65 years) have shown that following a course of 3 doses of Engerix-B (20 mcg/1 mL) given at 0, 1, and 6 months, the seroprotection (antibody titers ≥10 mIU/mL) rate for all individuals was 79% at Month 6 (5 months after second dose) and 96% at Month 7 (1 month after third dose); the GMT for seroconverters was 2204 mIU/mL at Month 7 (n=110).
- An alternate 3-dose schedule (20 mcg/1 mL given at 0, 1, and 2 months) designed for certain populations (eg, individuals who have or might have been recently exposed to the virus and travelers to high-risk areas) was also evaluated. At Month 3 (1 month after third dose), 99% of all individuals were seroprotected and remained protected through Month 12. On the alternate schedule, a fourth dose of Engerix-B (20 mcg/1 mL) at 12 months produced a GMT of 9163 mIU/mL at Month 13 (1 month after fourth dose) (n=373).
Persons Aged 40 Years and Older
- Among patients aged 40 years and older given Engerix-B (20 mcg/1 mL) at 0, 1, and 6 months, the seroprotection rate 1 month after the third dose was 88% and the GMT for seroconverters was 610 mIU/mL (n=50). In adults aged older than 40 years, Engerix-B produced anti-HBsAg antibody titers that were lower than those in younger adults.
Adult Dosage:
Give IM in deltoid muscle. 11–19yrs: 10mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later, or 20mcg at elected date and repeat 1 and 6 months later. ≥20yrs: 20mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later. Hemodialysis: 40mcg at elected date and repeat 1, 2, and 6 months later. High-risk or known/presumed exposure: consider hepatitis B immune globulin also. Booster dose: when appropriate, may use 20mcg for persons 11yrs of age and older; hemodialysis patients booster dose is 40mcg.
Children Dosage:
Give IM in anterolateral thigh or deltoid; see full labeling. Infants (mothers are HBsAG negative): 10mcg at birth and repeat 1 and 6 months later; infants (mothers are HBsAG positive) and children through age 10yrs: 10mcg at elected date and repeat 1 and 6 months later, or 10mcg at elected date and repeat 1, 2, and 12 months later. High risk or known/presumed exposure: consider hepatitis B immune globulin also. Booster doses: when appropriate, may use 10mcg for children age 10yrs or younger, or 20mcg for ages 11yrs and older.
ENGERIX-B Contraindications:
Yeast hypersensitivity.
ENGERIX-B Warnings/Precautions:
May defer in acute febrile illness or active infection. May be given SC only if risk of hemorrhage. Have epinephrine inj available. Immunocompromised. Latex allergy (prefilled syringes). Pregnancy. Nursing mothers.
See Also:
ENGERIX-B Classification:
HB.
Adverse Reactions:
Injection site reactions (eg, soreness, erythema, induration, swelling), fatigue, dizziness, headache; syncope, anaphylaxis.
Generic Drug Availability:
NO
How Supplied:
Single-dose prefilled Tip-Lok syringes (Pediatric/Adolescent dose)—1, 10 (without needles); Single-dose prefilled Tip-Lok syringes (Adult dose)—1, 10 (without needles); Single-dose vials (Adult dose)—1, 10