Department of Health and Human Services Centers for Disease Control and Prevention and National Institutes of Health. See current edition at: http://www.cdc.gov/biosafety/publications/index.htm 13.1.2 Patient Care Implications and Contraindications Cover vaccination sites with a sterile dry dressing (e.g., Telfa pad). Once the injection site is healed, no further barrier is necessary. As a precaution, protect injection sites that are exhibiting evidence of weeping, oozing or ulceration with a sterile dry dressing. In these circumstances, instruct patients to avoid direct contact of the injection site with susceptible individuals (e.g.; those who may be immunocompromised by disease or therapy). Instruct patients to avoid fathering a child for at least 4 months following therapy completion with the recombinant vaccine. Instruct patients receiving fowlpox vaccines to avoid direct contact with pet birds for at least 72 hours after vaccination or while there are any visible lesions at the injection site. Due to the method of manufacturing (virus grown in primary chicken embryo dermal cells), patients with a history of allergy to eggs or egg products should not receive the vaccine. 13.2 RECOMBINANT VACCINIA-PSA(L155)/TRICOM Other Names: PROSTVAC-V/TRICOM; PROSTVAC-V 13.2.1 Classification Recombinant vaccinia virus vector vaccine of the genus Orthopoxvirus. Product Description: Recombinant Vaccinia-PSA(L155)/TRICOM is a recombinant vaccinia virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules 64 Short Title: Enzalutamide Vaccine in mCRPC Version Date: 03/29/2022 (designated TRICOM ): B7.1, ICAM-1 (intercellular adhesion molecule-1), and LFA-3 (leukocyte function-associated antigen-3). The PSA gene coding sequence is modified to code for a single amino acid substitution [isoleucine to leucine at amino acid position 155 of the PSA antigen (designated L155)], which is designed to enhance immunogenicity. This modification occurs in a 10-mer, HLA-A2-restricted, immunodominant epitope of the antigen [designated PSA-3 (amino acids 154-163)]. An attenuated, live, derivative of the Wyeth (New York City Board of Health) strain of vaccinia virus is used as the parental virus for the recombinant vaccine. A plasmid vector containing the modified PSA gene and the genes for the three co-stimulatory molecules is used for in vivo recombination between the plasmid vector and parental vaccinia virus genome. The recombinant vaccine is manufactured by infection of primary chicken embryo dermal (CED) cells with the recombinant vaccinia virus. Vaccinia virus can infect mammalian cells and express the inserted transgenes, and is a potent immune stimulator, eliciting both a strong humoral and cellular immune response. Vaccinia virus is replication competent in mammalian cells, making systemic infections possible. 13.2.2 How Supplied Recombinant Vaccinia-PSA(L155)/TRICOM is supplied in vials containing 0.75 mL of the vaccine at a final viral concentration titer of 4 x 108 infectious units/mL formulated in phosphate- buffered saline containing 10% glycerol. 13.2.3 Preparation Thaw vials completely at room temperature. 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 (2 x 108 infectious units) into a 1 mL syringe for administration by subcutaneous injection. 13.2.4 Storage Store intact vials of Recombinant Vaccinia-PSA(L155)/TRICOM at –70oC or colder. 13.2.5 Stability Shelf-life 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 Vaccinia-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. 13.2.6 Route of Administration Recombinant Vaccinia-PSA(L155)/TRICOM  is administered by subcutaneous injection. 13.2.7 Special Handling and Precautions Vaccinia virus is classified as a Biosafety Level 2 agent. These agents are associated with human disease and are of moderate potential hazard to personnel and the environment. The recombinant vaccine is a preparation of a live virus affecting humans and contains DNA sequences derived from the human genome. Handle the recombinant vaccine as an infectious hazardous biological substance and dispose of waste materials as infectious hazardous biological waste, with 65 Short Title: Enzalutamide Vaccine in mCRPC Version Date: 03/29/2022 incineration according to local institutional policies and according to local, state, and federal regulations. 13.2.8 Preparation, Handling and Disposal Recommendations 1.