Clinical Study

Safety and Immunogenicity of a Human Papillomavirus Peptide Vaccine (CIGB-228) in Women with High-Grade Cervical Intraepithelial Neoplasia: First-in-Human, Proof-of-Concept Trial

Table 2

Colposcopic evaluation of patients.

TLA (mm2)Patients
01020304050607

Initial244.93493.68608.98638.98481.7130.8291.96
1 month0 (100%)462.46 (6.32%)486.72 (20.07%)0 (100%)75.700 (100%)182.10 (37.62%)
2 months0 (100%)441.12 (10.64%)381.8 (37.3%)0 (100%)48.150 (100%)149.78 (48.69%)
3 months0 (100%)403.2 (18.32%)286.61 (52.93%)0 (100%)0 (100%)0 (100%)104.73 (64.12%)

Response statusCRSDPRCRCRCRPR

Abbreviations
TLA: total lesion area.
TLA: total lesion area.
Complete response (CR) was considered as disappearance of all initial TLA; (PR) partial response if at least a 30% decrease of the initial TLA; progressive disease (PD) meant at least a 20% increase of the initial TLA and as stable disease (SD) if a reduction or an increase of the TLA compared to the initial value that is not enough for classification of the outcome as partial response or progressive disease.
% d e c r e a s e = T L A i n i t i a l T L A n a l / T L A i n i t i a l × 1 0 0 .