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Immune Deficiency Foundation. The national patient organization with the mission of improving the diagnosis and treatment of individuals with primary immune deficiency diseases, through research and education. IDF Concerns Regarding Vaccination Strategies. Fragile Population Identified
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Immune Deficiency Foundation • The national patient organization with the mission of improving the diagnosis and treatment of individuals with primary immune deficiency diseases, through research and education.
IDF Concerns Regarding Vaccination Strategies • Fragile Population • Identified • Not identified • Complications due to immunization • Complications due to contact with those immunized
IDF Risk Reduction Goals During Smallpox Vaccination Programs • Determine the natural history of vaccinia infection in PID patients. • Evaluate the protective benefit of IGIV. • Consider the development of immunologic screening tests for vaccination programs.
Assess the Clinical Utility • Of Vaccinia Antibodies • Test licensed IGIV products for Vaccinia antibody titers using appropriate assays and compare results to previously produced Vaccinia Immune Globulin. • Infuse licensed IGIV products into immunodeficient humans to determine the half life and recovery of Vaccinia antibodies to develop dosing information. Concurrently, measure Hepatitis B and Tetanus antibody titers to learn more about Vaccinia antibody catabolism. • Use licensed IGIV’s in animal models to assess their protective effects against Vaccinia infection. • Determine the protective effects in animal models of sera obtained during pharmacokinetic studies in immunodeficient humans.
IDF Working Group Recommendations • IGIV should be stockpiled if shown to be useful. • A hyperimmune globulin (VIG) should be produced. • Donor criteria • Identify a cGMP manufacturer • If hyperimmune globulin is administered, those with Severe Combined Immune Deficiency Syndromes, Wiskott-Aldrich Syndrome, Common Variable Immune Deficiency, DiGeorge anomaly, Combined Immunodeficiency (CID) syndromes, Ataxia Telangiectasia, and other T cell defects should be the recipients.