Safety and Feasibility Study of PVX7 Immunotherapy for Advanced Cervical Cancer in Women Who Completed Primary Treatment

What this Trial Is About

Researchers are evaluating the PVX7 immunotherapy vaccine in female patients with advanced cervical cancer who have completed their initial primary treatment. This phase 1 feasibility trial aims to study the safety and immune response triggered by the vaccine. Patients are randomized to receive the vaccine via two different methods to understand which administration route may be feasible and safe. Participants are randomly assigned in equal groups to receive PVX7 immunotherapy either by intramuscular injection or skin inoculation. The vaccination schedule includes doses at weeks 1, 5, and 9. One group receives pBI-11 DNA twice by intramuscular injection followed by a skin inoculation dose of TA-HPV, while the other group receives pBI-11 DNA twice followed by an intramuscular dose of TA-HPV. After vaccination, patients are followed for two years according to standard care protocols. During the trial, participants undergo regular safety monitoring to track adverse events and immune responses over 12 months. Researchers measure cellular immune response, overall immune response, and the presence of circulating HPV DNA. Participants need to comply with study procedures and avoid close contact with certain vulnerable individuals for one month after vaccination. The study is led by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and aims to assess the feasibility and safety of this immunotherapy approach in advanced cervical cancer patients.

A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients