The Food and Drug Administration, Center for Biologics Evaluation for Research (CBER), Laboratory of Plasma Derivatives has a requirement for research services for post-exposure treatment of pandemic influenza with FLUIGIV.
FDA has studied FLUIGIV in vitro, confirming that the product has anti-influenza antibody neutralizing activity 16-fold greater than that of comparator lots by hem-agglutination inhibition. FDA has also completed a Phase I study of tolerability and pharmacokinetics to assure that FLUIGIV can be given safely to ferrets. FDA modified the original protocol to enable human-level doses to be tolerated by ferrets, and determining the maximum serum concentration (Cmax) of subcutaneously delivered FLUIGIV to occur 2 days post infusion.
A phase II study of FLUIGIV for prevention of pdm09H1N1 disease in ferrets is complete and respiratory tissue viral burdens are pending. The purpose of this contract is to test FLUIGIV given after infection, to determine its effectiveness as a treatment.
Preclinical studies in ferrets will best determine the potential of a FLUIGIV to be effective in the setting of a pandemic outbreak. Efficacy demonstration has broad implications for pandemic preparedness, which then can be improved by prompt collection and manufacture of FLUIGIV for disease prevention in high-risk individuals, and treatment of antibiotic-resistant cases during a pandemic.
The contractor will provide support for phlebotomy, processing sera, collection of nasal washes, tissue collection and homogenization (for viral load and/or antibody measurements), and performance of TCID50 assays to assess tissue viral loads.
The period of performance is six months after receipt of order (ARO). Details are available under Solicitation Number: FDA-SOL-1135604.
