Hepatitis b virus subtype adw2 hbsag surface protein antigen

For hemodialysis patients, in whom vaccine-induced protection is less complete and may persist only as long as antibody levels remain above 10 mIU/mL, the need for booster doses should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster doses with ENGERIX-B should be given when antibody levels decline below 10 mIU/mL. 1 Data show individuals given a booster with ENGERIX-B achieve high antibody titers. (See CLINICAL PHARMACOLOGY.) There are alternate dosing and administration schedules which may be used for specific populations (see Table 2 and accompanying explanations). [See table below.] Children: Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 2, 12 months a 5 through 10 years of age 10 mcg/0.5 mL 0, 12, 24 months b Adolescents: 11 through 16 years of age 10 mcg/0.5 mL 0, 12, 24 months b 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 6 months 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 2, 12 months a Adults (>19 years) 20 mcg/1.0 mL 0, 1, 2, 12 months a a This schedule is designed for certain populations (e.g., neonates born of hepatitis B–infected mothers, others who have or might have been recently exposed to the virus, certain travelers to high-risk areas.

Studies have demonstrated a substantial increase in antibody titers after ENGERIX-B booster vaccination following an initial course with both plasma- and yeast-derived vaccines. (See CLINICAL PHARMACOLOGY.) See previous section for discussion on booster vaccination for adult hemodialysis patients. Known or Presumed Exposure to Hepatitis B Virus: Unprotected individuals with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, others experiencing percutaneous or permucosal exposure) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with ACIP recommendations 1 and with the package insert for HBIG.

Preparation for Administration: Shake well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. With thorough agitation, ENGERIX-B is a slightly turbid white suspension.

Do not administer if it appears otherwise. The vaccine should be used as supplied; no dilution is necessary. The full recommended dose of the vaccine should be used. Any vaccine remaining in a single-dose vial should be discarded. Dosing Schedules: The usual immunization regimen (see Table 1) consists of 3 doses of vaccine given according to the following schedule: first dose: at elected date; second dose: 1 month later; third dose: 6 months after first dose. [See table below.] a Two × 20 mcg in 1 or 2 injections.