Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

Wasserman, Richard L.; Lumry, William; Harris, James; Levy, Robyn; Stein, Mark; Forbes, Lisa; Cunningham-Rundles, Charlotte; Melamed, Isaac; Kobayashi, Ai Lan; Du, Wei; Kobayashi, Roger

Studies of an early RSV-IVIG, RespiGam®, in premature infants demonstrated the ability of this polyclonal anti-RSV hyperimmune globulin to reduce not only respiratory syncytial virus (RSV) infections but also other viral respiratory infections as well as otitis media [15, 16] . When this product was available, the American Academy of Pediatrics (AAP) stated that for children with severe immunodeficiencies receiving IG therapy during the winter months, physicians could consider the addition and/or substitution of the high titer RSV-IVIG for standard IG supplementation [17] . These data suggested that a polyclonal anti-RSV hyperimmune globulin would confer enhanced protection from infection. Despite the successful use of this RSV-IVIG in premature infants, it was voluntarily withdrawn after the introduction of a monoclonal anti-RSV (Synagis®) antibody that could be administered intramuscularly rather than intravenously as was required for the polyclonal antibody [14] . Consequently, a new IG formulation that meets all the standard criteria for treatment of PIDD (RI-002) was developed using plasma collected from individuals tested to have high titer anti-RSV antibodies [18] .