Ensure the thawed contents are at the bottom of the upright vial and vortex vigorously at high power for at least ten seconds prior to dose preparation. Withdraw 0.5 mL (1 x 109 infectious units) into a 1 mL syringe for administration by subcutaneous injection. Storage : Store intact vials of Recombinant Fowlpox-PSA(L155)/TRICOM at –70oC or colder. Stability : Shelf-life stability studies of the intact vials are ongoing. Once the intact vials are thawed, the vaccines maintain their potency for up to 4 days when stored at 2-8oC. Do not re-freeze thawed vials. Vials of Recombinant Fowlpox-PSA(L155)/TRICOM are for single-use only and do not contain a preservative. Administer prepared doses as soon as possible following preparation ( i.e., within one hour). If necessary, store prepared doses at 2-8oC for up to 4 hours following preparation. Route of Administration: Recombinant Fowlpox-PSA(L155)/TRICOM is administered by subcutaneous injection. Special Handling Fowlpox virus is classified as a Biosafety Level 1 agent. These agents are not known to cause disease in healthy human adults and are of minimal potential hazard to personnel and the environment under ordinary conditions of use. Clinicians can use techniques generally acceptable 62 Short Title: Enzalutamide Vaccine in mCRPC Version Date: 03/29/2022 for nonpathogenic material. The recombinant vaccine is a preparation of a live virus (infectious for birds) containing DNA sequences derived from the human genome. Handle the recombinant vaccine as a hazardous biological substance and dispose of waste materials as hazardous biological waste, with incineration according to local institutional policy and according to local, state, and federal regulations. Healthcare workers handling the recombinant fowlpox vaccine should avoid direct contact with pet birds for at least 72 hours after working with the agent. 13.1.1 Preparation, Handling and Disposal Recommendations 1.