{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"9"},{"groupId":"OG009","value":"9"}],"units":"Participants"}],"description":"DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.","groups":[{"description":"Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.","id":"OG000","title":"Part A: V935 LD"},{"description":"Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.","id":"OG001","title":"Part A: V934 LD(3)+V935 LD"},{"description":"Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.","id":"OG002","title":"Part A: V935 HD"},{"description":"Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.","id":"OG003","title":"Part A: V934 HD(3)+V935 HD"},{"description":"Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.","id":"OG004","title":"Part A: V934 HD(5)+V935 HD"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG005","title":"Part B: V935 LD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG006","title":"Part B: V934 LD(3)+V935 LD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG007","title":"Part B: V935 HD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG008","title":"Part B: V934 HD(3)+V935 HD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG009","title":"Part B: V934 HD(5)+V935 HD/V934 Booster"}],"paramType":"NUMBER","populationDescription":"Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.","reportingStatus":"POSTED","timeFrame":"Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period","title":"Number of Participants With Dose-Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}