Hepatitis B Immune Globulin (Human) products provide passive
immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack
rate of hepatitis B following use6-9. Clinical studies10,11 conducted prior to 1983 with hepatitis B
immune globulins similar to Nabi-HB indicate the advantage of simultaneous administration of hepatitis
B vaccine and Hepatitis B Immune Globulin (Human). The Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be
provided in certain instances of exposure based upon the increased efficacy found with that regimen in
neonates12. Cases of hepatitis B are rarely seen following exposure to HBV in persons with
preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of
concurrent hepatitis B vaccine and Hepatitis B Immune Globulin (Human) administration following
parenteral exposure, mucous membrane contact, or oral ingestion in adults. Infants born to HBsAgpositive
mothers are at risk of being infected with HBV and becoming chronic carriers13. The risk is
especially great if the mother is also HBeAg-positive14. Studies conducted with hepatitis B immune
globulins similar to Nabi-HB indicated that for an infant with perinatal exposure to an HBsAg-positive
and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at
birth with the hepatitis B vaccine series started soon after birth is 85-98percent effective in preventing
development of the HBV carrier state15-17. Regimens involving either multiple doses of Hepatitis B
Immune Globulin (Human) alone or the vaccine series alone have a 70-90percent efficacy, while a
single dose of Hepatitis B Immune Globulin (Human) alone has 50percent efficacy18. Since infants have
close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute
HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin
(Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV
infection19. Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV
infection. A single dose of Hepatitis B Immune Globulin (Human) is 75percent effective if administered
within two weeks of the last sexual exposure to a person with acute hepatitis B19.
Pharmacokinetics trials20 of Nabi-HB, Hepatitis B Immune Globulin (Human), given
intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those
reported by Scheiermann and Kuwert21. The half-life for Nabi-HB was 23.1 5.5 days. The clearance
rate was 0.35 0.12 L/day and the volume of distribution was 11.2 3.4 L. Maximum concentration of Nabi-
HB was reached in 6.5 4.3 days. The maximum concentration of anti-HBs and the area under the timeconcentration
curve achieved by Nabi-HB were bioequivalent to that of another licensed Hepatitis B
Immune Globulin (Human) when compared in the same pharmacokinetics trial. Comparability of
pharmacokinetics between Nabi-HB and a commercially available hepatitis B immunoglobulin indicate
that similar efficacy of Nabi-HB should be inferred.
6. Grady GF, and Lee VA: Hepatitis B immune globulin - prevention of hepatitis from accidental
exposure among medical personnel. N Engl J Med 1975; 293:1067-1070.
7. Seeff LB, et al.: Type B hepatitis after needle-stick exposure: Prevention with hepatitis B immune
globulin. Ann Int Med 1978; 88:285-293.
8. Krugman S, and Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural
history and prevention. N Engl J Med 1973; 288:755-760.
9. Hoofnagle JH, et al.: Passive - active immunity from hepatitis B immune globulin. Ann Int Med 1979;
10. Beasley RP, et al.: Efficacy of hepatitis B immune globulin for prevention of perinatal transmission
of the hepatitis B virus carrier state: Final report of a randomized doubleblind, placebo - controlled
trial. Hepatology 1983; 3:135-141.
11. Szmuness W, et al.: Passive active immunisation against hepatitis B: Immunogenicity studies in adult
Americans. Lancet 1981; 1:575-577.
12. Centers for Disease Control: Recommendations for protection against viral hepatitis.
Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985;
13. Shiraki Y, et al.: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic
carrier mothers. Am J Dis Child 1977; 131:644-647.
14. Beasley RP, et al.: The e antigen and vertical transmission of hepatitis B surface antigen. Am J
Epidemiol 1977; 105:94-98.
15.Wong VCW, et al.: Prevention of the HBsAg carrier state in newborn infants of mothers who are
chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B
immunoglobulin: Double-blind randomized placebo-controlled study. Lancet 1984; 1:921-926.
16. Poovorawan Y, et al.: Long term hepatitis B vaccine in infants born to hepatitis B e antigen positive
mothers. Archives of Diseases in Childhood 1997; 77:F47-F51.
17. Stevens CE, et al.: Perinatal Hepatitis B virus transmission in the United States: Prevention by
passive-active immunization. JAMA 1985; 253:1740-1745.
18. Jhaveri R, et al.: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive
mothers. J Pediatr 1980; 97:305-308.
19. Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating
transmission in the United States through universal childhood vaccination. Recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.
20. Data on file, Biotest Pharmaceuticals.
21. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after
intramuscular application in man. Develop Biol Standard 1983; 54:347.