Nabi-HB (Hepatitis B Immune Globulin (Human)) - Summary

NABI-HB SUMMARY

Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol fractionation process^1,2 with two added viral reduction steps described below. Nabi-HB is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only.

Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings:

• Acute Exposure to Blood Containing HBsAg
  
  Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.
• Perinatal Exposure of Infants Born to HBsAg-positive Mothers
  
  Infants born to mothers positive for HBsAg with or without HBeAg¹².
• Sexual Exposure to HBsAg-positive Persons
  
  Sexual partners of HBsAg-positive persons.
• Household Exposure to Persons with Acute HBV Infection
  
  Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient.

Nabi-HB is indicated for intramuscular use only.

See all Nabi-HB indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Nabi-HB (Hepatitis B Immune Globulin)

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. [2011.07]
BACKGROUND: A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to be well tolerated and immunogenic in adults. The current study tested a 2-, 4-, 6-month vaccination schedule and a higher dose formulation (10 mug mpHBV) in healthy infants... CONCLUSIONS: All 4 hepatitis B vaccines elicited high anti-HBs SPRs. After dose 3, anti-HBs GMT were highest in the 10 mug mpHBV group, but did not meet the predefined criteria for superiority. All vaccines were well tolerated.

Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.

A randomized trial of viral hepatitis prevention among underprivileged people in the Lyon area of France. [2011.06]
BACKGROUND: We compared the efficacy of two viral hepatitis B and C (VHBC) screening strategies, relative to no intervention, among underprivileged people (UP) living in shelters in the Lyon area... CONCLUSIONS: Health authorities must ensure widespread screening of UP, which is more effective when conducted in shelters than in screening centres.

Effect of high-flux hemodialysis on delayed hepatitis B virus vaccination response in hemodialysis patients. [2011.05]
OBJECTIVES: The aim of the study was to evaluate the effect of high-flux (HF) hemodialysis (HD) on delayed protective hepatitis B virus (HBV) antibody seroconversion in HD patients who had no response to the classic third dose of HBV vaccination... CONCLUSION: Hemodialysis patients who do not respond to the classic third dose of HBV vaccination could reobtain a delayed higher protective HBV antibody seroconversion rate by HF HD without other intervention.

Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. [2011.04.13]
CONTEXT: Alternative schedules more immunogenic than the standard hepatitis B vaccine regimen are needed in patients with human immunodeficiency virus 1 (HIV-1) infection. OBJECTIVE: To compare the safety and immunogenicity of 4 intramuscular double-dose and 4 intradermal low-dose regimens vs the standard hepatitis B vaccine regimen... CONCLUSION: In adults with HIV-1, both the 4 intramuscular double-dose regimen and the 4 intradermal low-dose regimen improved serological response compared with the standard HBV vaccine regimen. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00480792.

more studies >>

Clinical Trials Related to Nabi-HB (Hepatitis B Immune Globulin)

Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies [Recruiting]

Open Label Phase 3 Study of NABI-IGIV 10% [(HUMAN)] In Subjects With Primary Immune Deficiency Disorders (PIDD) [Completed]
The purpose of this study is to determine if NABI-IGIV (10%) is safe and effective in preventing serious bacterial infections in the treatment of patients with primary immune deficiency disorders when compared to historical control data. A subgroup of study patients will also have pharmacokinetic evaluations performed.

Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation [Not yet recruiting]
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.

A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation [Recruiting]

Efficacy of NicVAX in Smokers Who Want to Quit Smoking [Active, not recruiting]
The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies.

more trials >>