Should a CRIS screen not be available, the CRIS downtime procedures will be followed. Samples will not be sent outside NIH without NIH Intramural IRB notification and an executed MTA. SAMPLES SENT TO FIGG LAB x Venous blood samples will be colle cted in either a 4-mL or an 8-mL SST tube to be processed for serum and stored for future research. o Record the date and exact time of draw on the tube. Blood tubes may be kept in the refrigerator until pick-up. o For sample pick-up, page 102-11964. o For immediate help, call 240-760-6180 (main Blood Processing Core number) or, if no answer, 240-760-6190 (main clin ical pharmacology lab number). o For questions regarding sample processing, contact the Blood Processing Core (BPC) at NCIBloodcore@mail.nih.gov or 240-760-6180. o The samples will be processed, barcoded, and stored in the Figg lab until requested by the investigator. SAMPLES SENT TO SURGERY BRANCH CELL PRODUCTION FACILITY x Venous blood samples will be colle cted in 8-mL CPT tubes to be processed and stored for future research. o Record the date and exact time of draw on the tube. Blood tubes are kept at room temperature until pick-up. o Samples will be picked up by the research nurse or designee and transported to the Surgery Branch Cell Production Facility (S B-CPF) within 24 hours of blood draw. o The samples will be processed, barcoded, and stored in SB-CPF. SAMPLE COLLECTION SCHEDULE Collection Point Test/Assay Volume Blood (approx.) Type of Tube Location of Specimen Analysis Prior to Each Vaccination Immune- Monitoring 64 mL 8 mL CPT SST SB-CPF Figg Lab Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 36Each Follow-up Evaluation Immune- Monitoring 64 mL 8 mLCPT SSTSB-CPF Figg Lab IMMUNOLOGICAL TESTING x Apheresis may be performed prior to a nd approximately 2 weeks following the administration of the final vaccine product. At other time points, patient peripheral blood lymphocytes (PBL) will be obtained fro m whole blood by purification using centrifugation on a Ficoll cushion. Aliquots of these PBMC will be cryopreserved for immunological monitoring of cell function. x A variety of tests including evaluation of spec ific lysis and cytokine release, metabolomic and bioenergetic studies (using Seahorse), intracellular FACS of cytokine production, ELISA-spot assays, and lymphocyte subset analysis may be used to evaluate the immunological correlates of trea tment. In general, differences of 2- to 3-fold in these assays over the baseline measurement are indicative of true biologic differences. SAMPLE STORAGE ,TRACKING , AND DISPOSITION FOR SURGERY BRANCH CELL PRODUCTION FACILITY Blood and tissue collected during the course of this study will follow the Cell Tracking and Labeling System established by the SB-CPF. The Cell Tracking and Labeling System is designed to unambiguously ensure that patient/data verifi cation is consistent. The patients’ cell samples (blood or tissue) are tracked by distinct iden tification labels that include a unique patient identifier and date of specimen collection. Cryopreserved blood and tissue samples also bear the date the sample was frozen. All cryopreserved samples are tracked for freezer location and storage criteria. All samples are stored in monitored freezers/refrigerators in 3NW NCI-SB laboratories at specified temperatures with alarm systems in place. Serum samples will be sent to the BPC for storage. Samples will be barcoded and stored onsite or offsite at NCI Frederick Central Repository Services in Frederick, MD. All collected samples (blood or tissue) are entered into a central computer database with identification and stor age location, and this database is backed up every night. If, at any time, a patient withdraws from the study and does not wish for their existing samples to be utilized, the individual must provide a written request. Following receipt of this request, the samples will be destroyed and reported as such to the NIH Intramural IRB. Any samples lost (in transit or by a researcher) or destroyed due to unknown sample integrit y (i.e. broken freezer allows for extensive sample thawing, etc.) will be reported as such to the NIH Intramural IRB. Blood and tissue collected during the course of this study will be stored, tr acked, and disposed of as specified in protocol 03-C-0277. SAMPLE STORAGE ,TRACKING , AND DISPOSITION FOR FIGG LAB 5.6.1 Sample Data Collection All samples sent to the BPC will be barcoded, with data entered and stored in the LABrador (aka LabSamples) utilized by the BPC, and data w ill be updated to the NCI-SB central computer database weekly. This is a secure program, with access to LABrador limited to defined Figg lab personnel, who are issued individual user acc ounts.