Table 6.
Primary immune response at week 14: 2-Fold or Higher Rise in Combined HPV-16/18 E6/E7 SFU per 106 PBMCs from Baseline to Week 14 in IFN-gamma ELISpot for mITT population.
| Parameter | RF + EP (N = 114) |
FF + EP (N = 110) |
Difference in % (RF+EP – FF+EP) | 95% CI for Difference in %b | Non-Inferiority Test of H0: [p(RF+EP) – p(FF+EP)] ≤ −0.15b |
|---|---|---|---|---|---|
| Primary Endpoint: Immune Responsea, n/n* (%) | 89.9% (98/109) | 97.2% (103/106) | −7.3 | (−14.7, −0.7) | 0.022 |
Note: Percentage is based on n*.
Abbreviations: HPV = human papillomavirus; SFU = spot forming units; PBMCs = peripheral blood mononuclear cells; IFN = interferon; ELISpot = enzyme-linked immunospot; mITT = modified intent-to-treat; RF = refrigerated formulation of VGX-3100; FF = frozen formulation of VGX-3100; EP = electroporation; CI = confidence interval; H0 = null hypothesis; n = number of subjects in the formulation group who had immune response; n* = number of subjects in the formulation group with both baseline and Week 14 ELISpot;
a Defined as subjects who achieve a 2-fold or higher rise in combined HPV 16/18 E6/E7 SFU per 106 PBMCs from baseline to Week 14 in IFN-γ ELISpot. Fold rise is computed as Week 14 value/baseline value. In cases where baseline value is 0, the baseline value is set to the lowest detectable value of 1/3 in order to compute fold rise.
b CI and p-value obtained by Miettinen and Nurminen non-inferiority method.