Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT06315257
Brief Summary:
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
Detailed Description:
A Feasibility Trial of PVX7 in advanced cervical cancer patients who have completed primary definitive therapy.
* Safety and immunogenicity study
* Patients are randomized in a 1:1 ratio to two cohorts, up to 16 patients in each of intramuscular or skin scarification vaccine injection, up to 32 patients total
* Human Immunodeficiency Virus (HIV)-negative patients only
* Treatment dose: Arm A: pBI-11 DNA (3 mg) twice via intramuscular (IM) injection, followed by one dose of TA-HPV (2.5x105 pfu) via skin scarification; Arm B: pBI-11 DNA (3 mg) twice, followed by one dose of TA-HPV (107 pfu) via IM injection
* Schedule for administration: PVX7 vaccination at weeks 1, 5, and 9
* Follow-up for 2 years per standard of care (SoC)
Study:
NCT06315257
Study Brief:
Protocol Section:
NCT06315257