Evaluation of Potencies of Immune Globulin Products Against Hepatitis A

Abstract

Results | The anti-HAV IgG potency of GammaQuin was significantly higher than that of all the other preparations, followed by Beriglobin. Gamma-globulin, Subgam, and all the GamaSTAN S/D lots were not significantly different from each other (Figure , A). The anti-HAV neutralizing potency of GammaQuin was significantly higher than that of the other 8 preparations (Figure, B). Correlation between immunoassayand ARTA-derived potencies was high (Pearson coefficient, 0.95; P = .002).Modeling of anti-HAV IgG decay in plasma after IG inoculation 5 showed that postabsorption anti-HAV IgG levels greater than 10 mIU/mL, deemed protective against infection, 2 were maintained by Subgam and Gammastan-4 for 1 day and for Gamastan-5, Beriglobin, and GammaQuin for 19, 40, and 53 days, respectively, whereas none of the other 4 preparations tested reached potentially protective levels (Figure , C). Beriglobin and GammaQuin were the only 2 IG preparations that reached anti-HAV neutralizing antibody levels greater than 10 mIU/mL, which were maintained for 18 and 35 days after absorption, respectively (Figure , D).

Plasma Donors in the Southwestern United States Positively Contribute to the Diverse Therapeutic Antibody Profile of Immune Globulin Products

“…The twelve pools described in the preceding paragraph were also used to determine how differences in anti-HAV Ig titers relate to the capacity to neutralize HAV in vitro. High-titer plasma pools from the El Paso-TX center demonstrated a significantly greater capacity to neutralize HAV than the plasma pools from the mid-titer Midwest City-OK center, confirming that elevated anti-HAV Ig titers associate with greater inhibition of HAV infection in vitro, which is consistent with previous observations 10 . More importantly, the neutralization result underscores the clinical benefit plasma from these high-titer centers provides.…”

“…In the case of HAV, declining overall rates of hepatitis A infection, due particularly to increased vaccine coverage beginning in the mid-1990s, have had the effect of reducing naturally-acquired anti-HAV titers among adult plasma donors [4][5][6][7][8][9] . Consequently, available IG preparations have been found to fall short of potency expectations 10 .…”

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

“…In recent years, declining concentrations of anti-HAV (IgG) antibodies in plasma pools have raised concern regarding the efficacy of IG in PEP. 149 The safety profile of IG administration is excellent, except in recipients with IgA deficiency. Coadministration of IG with vaccines, such as measles, mumps, rubella, varicella and active HAV vaccines may partially blunt or neutralise the immune response of the particular vaccine.…”

“…75 Non-or low-response to inactivated HAV vaccines, previously linked to lack of a putative HAV receptor on T cells, is very rare 155 (See reviews on the humoral and cellular immune responses to HAV vaccines). 27,73,75,[145][146][147][148][149][150]154,155 Vaccine potency assays using a WHO international reference serum, and/or in-house assays, are used to compare vaccine biologic activity between manufacturers and results expressed in units or in microgram per weight. Two types of hepatitis A vaccines are currently used worldwide: a) Formalin-inactivated (''killed") hepatitis A virus vaccines.…”

The indications and safety of polyvalent immunoglobulin for post-exposure prophylaxis of hepatitis A, rubella and measles

“…The concentration of hepatitis A antibodies in the IMIG available may account for at least some of the dosing variation. 25,26,50 Neither passive immunization nor vaccination is used to prevent rubella post-exposure in most circumstances. Vaccination is recommended for non-pregnant contacts to provide ongoing protection against future rubella exposures.…”