Immune functional assays (US sites only) 7. CT* and bone scan * For subjects with allergies to contrast agents, MRIs for abdomen and pelvis may be performed. Only in cases where MRI is unavailable may a non - contrast CT be performed. For subjects enrolled in , MRI must be used as the primary imaging modality. Subsequent LTFU visits thereafter (every 6 Months ± 14 Days, phone call is acceptable ) 1. Survival status 2. Any anti -prostate cancer therapy 3. Update for newly diagnosed autoimmune disease 7.6 Safety Assessments Subjects will be followed during the Treatment phase of the study for any signs or symptoms of treatment - emergent toxicity by means of an abbreviated physical exam, hematology, serum chemistry panels, E CG, and recording of AEs and concomitant medications. 7.7 Biological and Immune Response Assessments To evaluate biological responses to vaccinations, serum as well as whole blood samples will be collected from all enrolled subjects at Screening, End - of-Treatment visit, and the first LTFU visit. Serum samples may be analyzed for immune and biomarker status, such as the development of antibodies to the vaccinia and fowlpox virus vectors, the PSA insert , other prostate specific antigens, tumor associated antigens , changes in cytokine and chemokine expression and circulating tumor markers. In addition, whole blood will be drawn into tubes containing an RNA preservative, which will allow for possible future analysis of selected tumor and immune cell gene expression profiles by quantitative PCR as well as other methods. Circulating tumor cell (CTC) characterization and immune function al analysis will only be performed for the subjects in the United States. Whole blood will be collected for the enumeration of CTC levels and for the isolation of peripheral blood mononuclear cells (PBMCs) for immune function al assays. PBMCs will be evaluated for PSA antigen - specific responses by ELISPOT and flow cytometric -based methods. Determinant spreading to other prostate antigens and tumor -associated antigens will also be examined. All evaluations will be performed at laboratories using standardized procedures. Subject samples may be kept for up to one year past the end of the trial for assay development, implementation, and data review. These described analyses may generate a large dataset that could potentially enable the identification of new potential biomarkers of disease prognosis and/or vaccine response. 7.8 Laboratory Tests and Radiological Assessments Samples of blood and urine will be obtained for the tests listed in the Schedule of Events. On the day of vaccination all samples will be collected prior to vaccine/placebo administration. Follow -up samples will be obtained as clinically indicated. All lab report print -outs will be collected and kept with the appropriate Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 51 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. source documents. Total blood volumes collected for the study will remain within Red Cross guidelines, which specify, “450 ± 50 mL of blood may be collected every 8 weeks.” Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 52 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 8.0 ADVERSE EVENTS For the purposes of this trial, “study vaccine” is defined as PRO STVAC -V/F. Study medication is defined as study vaccine, GM- CSF, or placebo. 8.1 Investigator’s Responsibilities Investigators are responsible for monitoring the safety of subjects who have entered this study and for assuring appropriate medical care is provided. In addition, investigators are responsible for alerting BNI or its designee to any event that seems unusual, even if the event may be considered an unanticipated benefit to the subject, and for reporting the event on the appropriate CRF or safety report form. Investigators are responsible for providing subjects who experience adverse events, especially SAEs that cause subjects to discontinue participation in the study, with appropriate medical care. Frequency of follow -up of any particular adverse event is left to the discretion of the investigator. Duration of follow -up and requirement for immediate SAE reporting (within 24 hours of becoming aware of the event) are described below. 8.2 Definition of Adverse Events (AE) An AE is any untoward (unfavorable, harmful, or pathologic) medical occurrence in a subject administered a pharmaceutical (investigational) product even if the event does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product (ICH E2A II/A/1, 21 CFR 312.32). For the purpose of this clinical study, adverse events include only treatment -emergent events which are either new or represent detectable exacerbations of pre- existing conditions. Adverse events may include, but are not limited to: 1. Subjective or objective symptoms spontaneously offered by the subject and/or observed by the Investigator or study staff including laboratory abnormalities of clinical significance. Any adverse events experienced by the subject through the completion of final study procedures. 2. AEs not previously observed in the subject that emerge during the protocol -specific AE reporting period, including signs or symptoms associated with metastatic castration- resistant prostate cancer that were not present before the AE reporting period 3. Complications that occur as a result of protocol -mandated interventions Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 53 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. For the purposes of this study, the following exceptions to the definitions above will NOT be considered an Adverse Event: Pre-existing condition: A pre -existing condition (documented on the medical history CRF) is not considered and AE unless the severity, frequency, or character of the event worsens during the study period. Preplanned hospitalization: A hospitalization planned before signing the informed consent form is not considered an SAE, but rather a therapeutic intervention. However, if during the pre- planned hospitalization an event occurs, which prolongs the hospitalization or meets any other SAE criteria, the event will be considered an SAE. Surgeries or interventions that were under consideration, but not performed before enrollment in the study will not be considered serious if they are performed after enrollment in the study for a condition that has not changed from its baseline level. Hospitalizations for social reasons or due to long travel distances are also not SAEs. Diagnostic testing and procedures: Testing and procedures should not be reported as adverse events or serious adverse events, but rather the cause for the test or procedure should be reported. 8.3 Definition of Expected and Unexpected Events 8.3.1 Expected Events Expected events are those that have been previously identified as resulting from administration of the investigational product. For the purpose of this study, an adverse event is considered expected when it appears in the current adverse event list, the Investigator’s Brochure, the package insert or is included in the informed consent document as a potential risk. An event will be considered expected if the event is thought to be related to a study procedure, and the event occurs with reasonable frequency and similar intensity in the day -to-day care of a patient with prostate cancer treated with GnRH agonists or bisphosphonates. Examples of adverse events that are expected during the course of treatment for prostate cancer with GnRH agonists include, but are not limited to malaise/fatigue, hot flashes/sweating, gynecomastia, testicular atrophy or pain, impotence, and clinically significant and non- significant alterations in laboratory parameters including transient increases in testosterone levels. For subjects taking bisphosphonates ( e.g., Zometa), expected events would include flu- like symptoms (fever, chills, myalgia, fatigue), injection site redness, swelling, and pain (for injection or infusion- delivered bisphosphonates); joint and/or muscle pain; osteonecrosis of the jaw, and renal insufficiency. Expected events associated with GM- CSF (at therapeutic doses) include mild to moderate headache, fever, arthralgia, chills, and myalgia. Injection site reactions such as pain, redness, swelling, induration, and prurit us, or systemic injection reactions such as fever ≥ 104°F; myalgia, headache, nausea, fatigue lasting less than 72 hours are expected events for PROSTVAC -V/F. If, however, the investigator considers an expected event to be unexpectedly severe or more frequent than usual for a patient with prostate cancer treated with GnRH agonists/antagonists, GM- CSF, or bisphosphonates, the event will be captured on the AE CRF (see below). Similarly, if the event is Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 54 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. associated with PROSTVAC -V/F, and is unexpectedly severe, such as a dose- limiting toxicity, it will also be recorded on the AE CRF. 8.3.2 Unexpected Events Unexpected events are those considered unexpected when it varies in nature, intensity or frequency from the information provided in the current adverse event list, the Investigator’s Brochure, the package insert or when it is not included the informed consent document as a potential risk. An event will be considered to be unexpected for GnRH agonist/antagonist, GM- CSF, or bisphosphonate therapy or a study procedure if it is not identified in the package insert, or is unexpectedly more severe or more frequent than events described in the package insert, or is related to PROSTVAC -V/F (with the exceptions for injection site and systemic reactions as noted above). 8.4 Collecting and Recording Adverse Events The Investigator will monitor the occurrence of adverse event for each subject during the course of the study. All AEs (as defined above) reported by the subject, observed by the Investigator, or documented in medical records will be listed on the AE CRF, whether believed by the Investigator to be related or unrelated to the study vaccine. All AEs must be reviewed, graded and causality determined by an Investigator listed on the form FDA 1572 at the research center reporting the event(s). Collection of adverse events begins at the time the subject signs informed consent and continues for 28 days following administration of the last dose of study medication. Adverse event terms should be recorded concisely, using acceptable medical terms. When possible, a diagnosis ( i.e., disease or syndrome) rather than the component signs and symptoms should be recorded on the CRF ( e.g., congestive heart failure rather than dyspnea, rales, and cyanosis). However, signs and symptoms considered unrelated to syndromes or diseases are to be recorded as individual adverse events on the CRF ( e.g., if congestive heart failure and severe headache are observed at the same time, each event is to be recorded as an individual adverse event). Only abnormal laboratory values that result in clinical sequelae or require medication for treatment should be recorded as an adverse event. The adverse event should not be recorded as a procedure or clinical measurement ( i.e., a laboratory or vital sign). The underlying reason for the procedure or the abnormal clinical measurements, and, whenever possible, a diagnosis, should be recorded. The diagnosis should be recorded; not the individual lab test name. Death is considered to be an outcome of an adverse event. The cause of death should be recorded on the AE CRF ( e.g., congestive heart failure with an outcome of death rather than the term “death”). Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 55 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 8.4.1 Progression of Underlying Malignancy It is anticipated that a proportion of subjects will experience disease progression. When clinical disease progress ion is identified, the clinical event which marks or identifies the disease progression should be reported as the adverse event term for standard AE reporting, including SAE reporting, per ICH definitions of AE and SAE as reviewed in Section 8.2 and Section 8.8 of this protocol, respectively. For the purpose of this study, progression of underlying malignancy is not considered an (S)AE. Hospitalization, prolonged hospitalization, or death due solely to the progression of underlying malignancy will be captured on the AE CRF, but may NOT be reported as an SAE. Clinical symptoms of progression may be reported as AEs if they cannot be determined to be exclusively due to the progression, or if they do not fit the expected pattern of progression for prostate cancer. Symptomatic deterioration may occur in the absence of radiographic evidence of tumor progression in some subjects . Alternatively, the disease progression may be so evident that the investigator may elect not to perform further assessments. In such cases, the determination of clinical progression is based on symptomatic deterioration. In these cases, efforts should be made to quantitatively document the progression of the underlying malignancy to the extent possible. If there is any uncertainty about an adverse event being due to the progression of prostate cancer, it should be reported as an (S)AE . 8.4.2 Pregnancy of a Female Partner For the purposes of this study, pregnancy of a female partner will be captured using a modified SAE report form, however; the event is not considered an SAE and will be reported to the appropriate regulatory authorities in the annual safety update. Partner pregnancies will be followed through the term of the pregnancy or pregnancy termination and the birth of the child after the female partner has signed the Pregnant Partner Informed Consent Form. Subjects and their partners will be counseled as to any possible known risks to either the partner or the child. 8.4.3 Accidental Transmission of Vaccinia Virus Accidental transmission of vaccinia virus to a clinic staff member or a member of the subject’s family or personal contacts must be reported to the Investigator as soon as possible, but no later than 24hours after he/she becomes aware. The Investigator must notify an Infectious Disease Specialist in the Pharmacovigilance Group (PVG) if there is a suspected serious vaccinia reaction as soon as possible, but no later than 24 hours after he/she becomes aware.. The Investigator should contact the BNI study Medical Monitor if there are specific questions in regard to the potential vaccinia reaction. A swab of the suspe cted lesion may be obtained from the study subject for confirmatory testing prior to administration of VIG. The Investigator should refer to the Management Plan for Potential Serious Vaccinia Reaction for recognition, diagnosis and treatment of a rare pote ntial serious vaccinia reaction. This plan also describes when VIG is indicated for use and administration procedures. For further information or for a Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 56 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. supply of VIG in the United States, contact the Centers for Disease Control at (877) 554- 4625. For centers outside the United States, VIG suppliers (where known) are listed in the Study Instruction Manual. The Investigator should refer to the Management Plan for Potential Serious Vaccinia Reaction. If VIG treatment is warranted, the person receiving VIG must sign the Consent Form to Administer Vaccinia Immune Globulin (VIG) PRIOR to administration of VIG. 8.5 Assessment of Relationship to Study Drug (Causality) Investigators are required to assess the causal relationship (i.e., whether there is reasonable poss ibility that the study drug caused the event) using the following definitions: Unrelated: Another cause of the adverse event is more plausible; a temporal sequence cannot be established with the onset of the adverse event and administration of the investigational product; or, a causal relationship is considered biologically implausible. Possibly Related: There is clinically plausible time sequence between onset of the adverse event and administration of the investigational product, but the adverse event could also be attributed to concurrent or underlying disease, or the use of other drugs or procedures. Possibly related should be used when the investigational product is one of several biologically plausible adverse event causes. Definitely Related: The adverse event is clearly related to use of the investigational product. 8.6 Severity of Adverse Events (Grading) Adverse events will be categorized and graded by the Investigator using standard terminology for grading the severity (intensity) of the AE. This study will use the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v 4.0) five- point scale, Grades 1 to 5 with unique clinical descriptions of severity for each referenced AE.A copy of the CTCAE version 4.0 can be downloaded from the CTEP website at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. A hard copy will be provided by BNI upon request. Should a subject experience any AE not listed in the CTCAE v4.0, the following grading system should be used to assess severity: Table 9-1 Adverse Event Grading Criteria CTCAE Grade Equivalent To: Definition Grade 1 Mild AE Experiences which are usually transient, requiring no special treatment, and no disruption of normal daily activity Grade 2 Moderate AE Experiences which introduce some level of inconvenience or concern to the subject, and which may interfere with daily activities, but are usually ameliorated by simple therapeutic measures Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 57 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Grade 3 Severe AE Experiences which are unacceptable or intolerable, significantly interrupt the subject’s usually daily activity, and require systemic drug therapy or other treatment Grade 4 Life threatening / disabling AE Experience which causes the subject to be in imminent danger of death Grade 5 Death related to AE Experiences resulting in subject death 8.7 Dose Modifications for Toxicity There are no dose reductions or modifications for dose toxicity for PROSTVAC -V/F. If subjects experience intolerable toxicities due to PROSTVAC -V/F, they will be removed from treatment and will be immediately rolled over onto the Long- Term Follow -Up (LTFU) phase of the study and followed for safety and vital status per protocol. 8.8 Definition of Serious Adverse Events Note: The terms “severe” and “serious” are not synonymous. Severity (or intensity) refers to the grade of an AE (see below). “Serious” is a regulatory definition. A serious adverse event (experience) or reaction is an untoward medical occurrence that at any dose: • Results in death (i.e., the AE actually causes or leads to death) • Is life -threatening (with regards to determining if an AE is serious , “life-threatening” is defined as an AE in which the subject was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe. If either the Investigator or the Sponsor believes that an AE meets the definitio n of life -threatening, it will be considered life- threatening). • Requires in- patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the subject’s ability to conduct normal life functions) • Results in a congenital anomaly/birth defect • Is medically significant Medical and scientific judgment should be exercised in deciding whether other situations, such as important medical events that may not be immediately life- threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should also be considered serious . Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse). Given the Investigator’s Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 58 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. perspective may be informed by having actually observed the event, the Sponsor is likely to have broader knowledge of the drug and its effects to inform its evaluation of the significance of the event, if either the Sponsor or the Investigator believes that the event is serious, the event will be considered serious. For the purposes of this trial, death is an expected outcome of disease progression and/or sequelae and will not be considered an SAE . Death due to causes other than underlying disease progression should be reported on the AE and SAE page and should also be reported on the CRF death page. For the purposes of this trial, the following will NOT be considered SAEs: • Hospitalizations < 24 hours, or for planned surgeries or procedures. • Progression of underlying malignancy as a stand- alone event term; clinical events associated with disease progression should be reported as AEs or SAEs as applicable. • Death due to progression of underlying mal ignancy 8.9 Definition of Unexpected Serious Adverse Events An unexpected SAE is one in which the specificity or severity is not consistent with the current applicable product information (Investigators’ Brochure or drug prescribing label), or one that has not been observed previously (rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product). 8.10 Definition of Suspected Adverse Reaction The FDA has published guidance on the reporting of SAEs (Safety Reporting requirements for INDs and BA/BE studies, Dec ember 2012) . This document directs Sponsors to consider more carefully the adverse events that are reported in an expedited (urgent) fashion to the FDA. Key elements of this guidance are outlined below: The guidance defines any adverse event for which there is a “reasonable possibility” that the drug caused the adverse event as a Suspected Adverse Reaction. “Reasonable Possibility”, for the purposes of safety reporting, means there is evidence to suggest a causal relationship between the drug and the adverse event. Examples of evidence that would suggest a causal relationship between the drug and the adverse event are: • A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure (e.g., angioedema, blood dyscrasias, rhabdomyolysis, hepatic injury, anaphylaxis, and Stevens -Johnson Syndrome). • One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g., include tendon rupture or heart valve lesions in young adults, or intussusception in healthy infants). If the event occurs in association with other factors strongly suggesting causation (e.g., strong temporal association, event recurs on rechallenge), a single case may be sufficiently Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 59 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. persuasive; but often, more than one occurrence (from one or multiple studies) would be needed before the Sponsor could make a determination of whether the drug caused the event. • An aggregate analysis of specific events that can be anticipated to occur in the study population independent of drug exposure. Such events include known consequences of the underlying disease or condition under investigation (e.g., symptoms or disease progression), or events unlikely to be related to the underlying disease or condition under investigation, but commonly occur in the study population independent of drug therapy (e.g., cardiovascular events in an elderly population). An aggregate analysis (across studies) will identify those events that occur more frequently in the drug treatment group than in a concurrent or historical control group. This definition of “suspected adverse reaction” and the application of the “ reasonable possibility” causality standard is considered to be consistent with the concepts and discussion about causality in the International Conference on Harmonization (ICH) E2A guidance. 8.11 Documenting and Reporting of Adverse Events and Serious Adverse Events The Investigator is responsible for ensuring that all AEs and SAEs that are observed or reported during the study, as outlined in the prior sections, are recorded on the CRF. An event may qualify for expedited reporting to worldwide regulatory authorities if it is a Serious Adverse Event, Serious Adverse Drug Reaction or Suspected Unexpected Serious Adverse Reaction (SUSAR) in line with relevant legislation, including the European Commission Clinical Trials Directive (2001/20/EC). Expectedness of SAEs will be determined by BNI using the reference safety information specified in the Investigator’s Brochure. All investigators will receive a safety letter notifying them of relevant SUSAR reports. In accordance with the European Commission Directive 2001/20/EC, BNIT or designee will notify the relevant Ethics Committees in concerned Member States of applicable SUSARs as individual notifications or through a periodic line listing. The Sponsor makes the determination of expedited reporting of an SAE to Regulator y Authorities. Regulatory Authorities, Institutional Review Boards/Research Ethics Boards/Independent Ethics Committees (IRBs/REBs/IECs), and Principal Investigators will be notified of SAEs in accordance with applicable requirements (e.g., GCPs, ICH guidelines, national regulations, and local requirements). The Investigator is responsible for complying with the responsible IRB/IEC’s procedures of adverse event reporting. It is the responsibility of the Investigator to promptly inform the relevant IRB/IEC of these new adverse events/risks to subjects, in accordance with the US FDA Code of Federal Regulations (CFR) 21 CFR 312.66. Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 60 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. BNI has an internal medical safety review committee that will review and evaluate accumulating safety data from the entire clinical trial database for PROSTVAC -V/F at appropriate intervals (e.g., quarterly) to identify new safety signals or increased frequency of events. 8.12 Adverse Event Reporting Period The AE reporting period for this study begins with signing of the informed consent and ends 28 days following administration of the last dose of study medication . If an SAE is present at the EOT Visit, the SAE (and associated AEs and concomitant medications) should be followed to resolution or until the Investigator assesses the subject as stable, or the subject is lost to follow - up or withdraws consent. Resolution/stable means the subject has returned to baseline state of health or the Investigator does not expect any further improvement or worsening of the event. New SAEs wil l be collected until 28 days following administration of the last dose of study medication . If an SAE comes to the attention of the investigator after the end of the study, information regarding the SAE should be collected and reported only if assessed as possibly or definitely related by the investigator. 8.13 Assessment of Adverse Events Investigators will assess the occurrence of AEs and SAEs at all subject evaluation time points during the study. All AEs and SAEs whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded in the subject’s medical record and on the AE CRF and, when applicable, on the Serious Adverse Even t (SAE) report form. Each recorded AE or SAE will be described by its duration (i.e., start and end dates), severity, regulatory seriousness criteria (if applicable), suspected relationship to the investigational product, and any actions taken. Any SAE tha t occurs after the subject signs informed consent and until 28 days following administration of the last dose of study medication, irrespective of the treatment received by the subject, must be reported to the PVG within 24 hours of the investigator learning of the event. 8.14 Serious Adverse Events BNI is required to expedite to worldwide regulatory authorities reports of Serious Adverse Events, Serious Adverse Drug Reactions or Suspected Unexpected Serious Adverse Reactions (SUSARs) in line with relevant legislation, including the European Commission Clinical Trials Directive (2001/20/EC); therefore, BNI (or the CRO on the behalf o f BNI) must be notified immediately regarding the occurrence of any SAE or SADR that occurs after the subject consents to participate in the study, including SAEs/SADRs resulting from protocol - associated procedures as defined in relevant legislation including 2001/20/EC, performed from screening onwards. Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 61 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. All SAEs (initial and follow -up information) will be reported electronically through Remote Data Capture (RDC) platform within 24 hours of the discovery of the event or information. Manual SAE report forms are available in the Study Instructions Manual, however manual SAE report forms may be faxed to PVG only in the event RDC is not functioning, and must be entered into RDC when it becomes available . The Sponsor may request follow -up and other additional information from the Investigator (e.g., hospital admission/discharge notes and laboratory results). All deaths should be reported with the primary cause of death as the AE term, as death is typically the outcome of the event, not the event itself. The primary cause of death on the autopsy report should be the term reported. Autopsy and postmortem reports must be forwarded to the Sponsor’s Medical Monitor, or designee, as outlined above. If study drug is discontinued because of an SAE, this information must be included in the SAE report. Investigators must report SAEs to their governing IRBs/ECs in writing as soon as possible and in accordance with national and local laws and regulations. 8.15 Treatment and Follow -up of Adverse Events or Serious Adverse Events From the time the subject signs informed consent until 28 days after the last vaccination, all untoward medical events (as defined in Section 8.2 and exceptions as noted in Section 8.4 ) will be documented as (S)AEs through the Treatment phase of the study or through the last visit of the Treatment phase of the study for subjects who withdraw early. All (S)AEs assessed as not related to study vaccine will be followed as clinically indicated until resolved, stabilized, or if non - resolving, until 28 days after the last vaccination, whichever comes first. If a clear explanation is established, it should be recorded on the CRF. If an SAE is assessed as possibly or definitely related to study vaccine, it must be followed until either the event has resolved, stabilized, or is deemed to be non - resolvable by the investigator. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 62 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 9.0 STATISTICAL CONSIDER ATIONS The full details of the trial planning computations and planned analyses are contained in a separate Statistical Analysis Plan.