5.1.1.2 Adjuvant The adjuvant Montanide™ ( ISA 51 VG) is a mixture of highly purified mineral oil and mannide monooleate (derived from vegetable grade olive oil). It is manufactured according to GMP and should be stored in vials as an emulsion at room temperature. 5.1.2 PolyPEPI 1018 Product Preparation and A dministration PolyPEPI 1018 final vaccine product will be prepared at the clinical site prior to injection by the physician or the nurse according to standard operating procedure and should be administered as soon as possible following preparation. The peptide solutions (see Section 5.1.1.1) should be thawed and incubated at room temperature with the adjuvant Montanide™. A 4-mL volume of the final PolyPEPI1018 product will be prepared by mixing (emulsifying) each of the peptide solutions with an equal volume of the adjuvant Montanide™. Each dose of the final PolyPEPI 1018 product w ill contain 0.8 mg peptides per 1 mL (4 peptides) solution + 0. 4 mg peptides per 1 mL (2 peptides) solution plus 2 mL adjuvant. Prior to the PolyPEPI1018 administration , the subject’s body temperature should be checked and the vaccine should only be administered if the subject’s body temperature is <38 ºC. Each subject will receive a total of four 1 mL SC injections of the final PolyPEPI 1018 product (i.e., one 1 mL SC injection per predetermined anatomic site, (preferably draining to axillary or inguin al lymph nodes). A pause of a few minutes should be observed after the first Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 40 of 81 CONFIDENTIAL injection to check for side effects. The remaining injections can be subsequently administered without pause.