J Korean Med Sci.  2016 Dec;31(12):1937-1942. 10.3346/jkms.2016.31.12.1937.

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products

Affiliations
  • 1Center for Vaccine Evaluation and Study, Medical Research Institute, Ewha Womans University School of Medicine, Seoul, Korea. kaykim@ewha.ac.kr
  • 2Department of Pediatrics, Ewha Womans University School of Medicine, Seoul, Korea.

Abstract

The worldwide seroprevalence of hepatitis A virus (HAV) and hepatitis B virus (HBV) has changed over the last two decades, indicating a declining incidence of HAV and HBV infections. Therefore, vaccinations against HAV and HBV are recommended for unimmunized people before traveling to an endemic area. Unfortunately, primary antibody deficiency (PAD) patients can only obtain humoral immunity through intravenous immunoglobulin G (IVIG) replacement and not from vaccination because of a defect in antibody production. However, few studies have analyzed the titers of antibodies against HAV or HBV in IVIG products. In this study, the titers of anti-HAV and anti-HBs antibodies were measured in nineteen lots of IVIG products from five manufacturers from three countries (A, B from Korea; C, D from Japan; and E from the USA), and trough titers in plasma were estimated. Concentrations of anti-HAV antibody ranged from 1,888-8,927 mIU/mL and estimated trough titers exceeded the minimal protective value in all evaluated IVIG products. Concentrations of anti-HBs antibody ranged from 438-965 mIU/mL in products A and B and were 157, 123, and 1,945 mIU/mL in products C, D, and E, respectively. Estimated trough titers in products A, B, and E exceeded the minimal protective value but those in products C and D did not reach this threshold. These data demonstrated that available IVIG products generally provide sufficient antibodies against HAV and HBV to protect patients with PAD, although the trough concentrations of anti-HBs antibody in two IVIG products did not reach the minimum protective value.

Keyword

Antibody; Hepatitis A Virus; Hepatitis B Virus; Intravenous Immunoglobulin

MeSH Terms

Antibodies*
Antibody Formation
Hepatitis A Antibodies
Hepatitis A virus
Hepatitis A*
Hepatitis B virus*
Hepatitis B*
Hepatitis*
Humans
Immunity, Humoral
Immunoglobulin G
Immunoglobulins*
Immunoglobulins, Intravenous
Incidence
Japan
Korea
Plasma
Seroepidemiologic Studies
Vaccination
Antibodies
Hepatitis A Antibodies
Immunoglobulin G
Immunoglobulins
Immunoglobulins, Intravenous

Figure

  • Fig. 1 Expected trough levels of anti-hepatitis A virus (HAV) antibody (A) and anti-hepatitis B surface (HBs) antibody (B) in various intravenous immunoglobulin G (IVIG) products, assuming an infusion dose of 400 mg/kg. Short bars indicate the geometric mean and long bars indicate the minimum protective concentrations of anti-HAV and anti-HBs antibodies (20 mIU/mL and 10 mIU/mL, respectively). Numbers in brackets indicate different lot numbers of the same product.


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