Scientific Publications by FDA Staff
Vox Sang 2004 Feb;86(2):125-9
Intravenous immunoglobulin products contain neutralizing antibodies to vaccinia.
Goldsmith JC, Eller N, Mikolajczyk M, Manischewitz J, Golding H, Scott DE
Goldsmith JC, 40 W Chesapeake Ave,Suitte 308, Towson, MD 21204 USA Immune Deficiency Fdn, Towson, MD USA US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA
BACKGROUND AND OBJECTIVES: Individuals with primary or secondary immune-deficiency diseases may be at risk for vaccinia infection if widespread smallpox-immunization programmes are implemented in the United States of America (USA) for bioterrorism preparedness. The objective of this study was to determine whether commercial immune globulin (intravenous, human) products contain biologically active antibodies to vaccinia that have the potential to protect people, with immune deficiencies, from complications of vaccinia. MATERIALS AND METHODS: Eight currently United States (US)-licensed and two European intravenous immunoglobulin (IVIG) products were tested in a vaccinia plaque-reduction neutralization assay. The in vivo activity of five of these lots was assessed in severely immune-deficient mice. RESULTS: All tested products contained neutralizing anti-vaccinia activity, in vitro and in vivo. CONCLUSIONS: The use of IVIG by individuals with inherited or acquired humoral immune deficiencies may provide some protection if they are inadvertently exposed to vaccinia.
|Category: Journal Article, Peer|
|PubMed ID: #15023182|
|Includes FDA Authors from Scientific Area(s): Biologics|
|Entry Created: 2011-10-04||Entry Last Modified: 2012-08-29|