Refer to word document for this table Supplementary Table 1: AEs amongst all patients treated on trial Refer to word document for this table
Seroreactivity (any timepoint) - Endpoint ELISA Supplemental Table 2: Number of patients in each cohort with any seroreactivity against the candidate antigens (HPV 16,18 E6 and E7) at (A) any timepoint following vaccination and (B) three months following final vaccination A Seroreactivity (any timepoint) - Endpoint ELISA Cohort 1 Cohort 2 All Patients HPV16 E6 3/5 (60.0%) 6/12 (50.0%) 9/17 (52.9%) HPV16 E7 8/12(66.7%) 11/17 (64.7%) HPV18 E6 1/5 (20.0%) 7/12 (58.3%) 8/17 (47.1%) HPV18 E7 5/5 (100%) 10/12 (83.3%) 15/17 (88.2%) Any Antigen 12/12 (100%) 17/17 (100%) B Seroreactivity (three months following final vaccination) - Endpoint ELISA Cohort 1 Cohort 2 All Patients HPV16 E6 1/4 (25.0%) 1/8 (12.5%) 2/12 (16.7%) HPV16 E7 2/4 (50.0%) 3/8 (37.5%) 5/12 (41.6%) HPV18 E6 2/8 (25.0%) 3/12 (25.0%) HPV18 E7 4/4 (100%) 5/8 (62.5%) 9/12 (75.0%) Any antigen
HPV16 Specific CD8+ T cells expressing activation markers and lytic proteins (% of total CD3+CD8+) Patient ID Flow Cytometry Output Pre MEDI0457 Post MEDI0457 Difference 01 CD137+GrzA+GrzB+Prf+ 0.0% CD69+GrzA+GrzB+Prf+ CD38+GrzA+GrzB+Prf+ 02 0.33% 0.68% 0.57% 03 0.17% -0.17% 0.30% -0.30% 05 0.24% 0.21% -0.21% 09 0.18% -0.18% 0.28% 1.12% 10 0.07% 0.52% 0.45% 1.16% 1.38% 11 13 0.08% -0.08% 0.86% 0.89% 0.03% 0.34% 0.50% 0.16% Supplemental Table 3: Flow cytometry output frequencies for HPV16 specific CD8+ T cells before and after treatment with MEDI0457
HPV18 Specific CD8+ T cells expressing activation markers and lytic proteins (% of total CD3+CD8+) Patient ID Flow Cytometry Output Pre MEDI0457 Post MEDI0457 Difference 01 CD137+GrzA+GrzB+Prf+ 0.11% 0.0% -0.11% CD69+GrzA+GrzB+Prf+ 0.32% -0.32% CD38+GrzA+GrzB+Prf+ 02 0.04% 0.14% 03 -0.04% 05 0.17% 0.35% 0.18% 0.34% 0.06% -0.28% 09 0.40% 1.33% 10 0.05% 0.24% 0.19% 0.83% 1.11% 11 0.29% -0.29% 13 0.07% 1.21% 1.03% Supplemental Table 4: Flow cytometry output frequencies for HPV18 specific CD8+ T cells before and after treatment with MEDI0457
Supplementary Figure S1A: Flow Cytometry Gating for assessment of CD3+ CD8+ cells SSC Dump Channel CD8 FSC CD3 CD3
Before Activation (Negative After Activation (Positive Supplementary Figure S1B: Differential expression of CD38, CD69 and CD137 on CD3+ CD8+ cells before and after activation Before Activation (Negative Control) After Activation (Positive Control) CD38 CD69 CD137