Unpack the shipment contents and place the cardboard box containing vaccine vials into a freezer with a monitored temperature control. ETBX-011, ETBX-051 and ETBX-061 vials should be stored at ≤ -60°C. Receiver must stop the temperature monitoring device by turning off the power switch (instructions for handling and operation of temperature monitoring device will be provided with the package). 14.1.7 ETBX dose preparation and administration The dose of ETBX vaccine to be injected is 5x1011 VP per 1mL. Prior to injection, the appropriate vial should be removed from the freezer and allowed to thaw at controlled room temperature (20–25°C, 68-77°F) for at least 20 minutes and not more than 30 minutes, after which it should be kept at 2-8°C (35–46°F). The vaccine is stable in the vial for at least 8 hours after removal from the freezer when kept refrigerated at 2-8°C (35-46°F). Once the vaccine has been thawed, it must not be refrozen. Each vial is sealed with a rubber stopper and has a white flip-off seal. The end user of the product will need to flip the white plastic portion of the cap up/off with their thumb to expose the rubber stopper and then puncture the stopper with an injection needle to withdraw the liquid. The rubber stopper is secured to the vial with an aluminum-crimped seal. The thawed vial should be swirled and then, using aseptic technique, the pharmacist or pharmacist designee should withdraw the appropriate volume from the appropriate vial using an appropriately sized syringe. The thawed drug product may be stored at 2 – 8°C in the vial or syringe for a total of up to 8 hours prior to delivery to the patient, if necessary. Instructions for Dose Preparation – 5 x 1011 Virus Particles Withdraw 1 mL of contents from the vial, prepare the injection site with alcohol, and administer to the subject by SC injection without any further manipulation (refer to the vial label for a description of the vialed ETBX vaccine concentration). 14.1.8 Administration Please refer to section 3.2.3. 14.1.9 Other Information The Ad5 [E1-, E2b-] vector is non-replicating and its genome does not integrate into the human genome. However, since this is a non-replicating recombinant virus, it is recommended that it be handled under Biosafety Level-2 conditions. Any vialed ETBX vaccine material that has been used in the study should be autoclaved or incinerated after use according to institutional policy and according to local, state and federal regulations. 77 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 14.1.10 Incompatibilities None known 14.2 M7824 (BINTRAFUSP ALFA , MSB0011359C) 14.2.1 Source/Acquisition and Accountability M7824 is manufactured and supplied for the trial by EMD Serono Research and Development Institute. The investigator or designee (e.g.