Trial procedures
CIN
CIN 3, CIN
Participants were randomly assigned in a 1:1:1:1 ratio to either the low-dose, intermediate-dose, or high-dose IGMKK16E7 groups or the placebo group. We calculated sample size based on the results of the GLBL-101c clinical study targeting CIN 3 (Random assignment was performed with the use of a web-based system by minimization (dynamic balancing) and was stratified according to center, CIN grading (CIN 2 or 3), and HPV genotype (HPV-16 only or HPV-16 and other types). All patients received 4 rounds of oral immunization at weeks 1, 2, 4, and 8. Low-dose (0.5 g/day), intermediate-dose (1.0 g/day), or high-dose (1.5 g/day) IGMKK16E7 or placebo were administered orally after fasting once each morning for 5 days during each treatment week. IGMKK16E7 is an attenuated 