Trial registration
CIN
REGRESSION, CERVICAL CANCER, CIN
jRCT2031190034.Although cervical cancer risk has decreased in response to prophylactic human papillomavirus (HPV) vaccines, many low- and middle-income countries, especially in Eastern Mediterranean, Southeast Asian, and Western Pacific regions, lack robust implementation of prophylactic vaccination, and need for additional HPV-targeting therapies remains urgent (Because CIN 2/3 is a cervical mucosal lesion, we hypothesized that induction of mucosal Th1 cellular immunity against HPV would be more effective for immunological elimination of CIN 2/3 than induction of systemic immunity. Several studies have demonstrated that integrin β7To improve the efficacy of this vaccination strategy, we have optimized surface expression of HPV-16 E7 on Here, we conducted a phase I and /II double-blind, placebo-controlled, randomized clinical trial in which 165 patients with HPV-16–positive CIN 2/3 were administered oral IGMKKK16E7 or placebo. We assessed IGMKK16E7 vaccine safety and therapeutic efficacy against HPV-16–positive CIN 2/3 as measured by clinical lesion regression.