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Research Letter
January 09, 2017

Evaluation of Potencies of Immune Globulin Products Against Hepatitis A

Author Affiliations
  • 1Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
  • 2Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. Published online January 9, 2017. doi:10.1001/jamainternmed.2016.9057

Passive immunization with human immune globulin (IG) is recommended for prophylaxis against hepatitis A and infection with its causative agent, hepatitis A virus (HAV). Immune globulin preparations administered intramuscularly (0.02 mL/kg) may confer protection for up to 3 months.1 Because anti-HAV antibody levels are declining in plasma donors from developed countries,2 we evaluated antibody levels in currently marketed IG products. Several products had lower-than-expected anti-HAV potencies, potentially conferring protection of reduced magnitude or duration against hepatitis A.

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