Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

Phase 2 Terminated 16 enrolled PapiVax Biotech, Inc. Parexel · collab

Non-randomizedParallel-groupQuadruple-blindTreatment

Summary

* To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen * To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

Timeline

Start: 2019-05-22
Primary completion: 2022-06-08
Completion: 2022-06-08

Outcome

Outcome not reported

Stopped (Enrollment): “Slow recruitment/funding”

Publications

Results Einstein MH, Roden RBS, Ferrall L, Akin M, Blomer A, Wu TC, Chang YN. Safety Run-in of Intramuscular pNGVL4a-Sig/E7(detox)/HSP70 DNA and TA-CIN Protein Vaccination as Treatment for HPV16+ ASC-US, ASC-H, or LSIL/CIN1. Cancer Prev Res (Phila). 2023 Apr 3;16(4):219-227. doi: 10.1158/1940-6207.CAPR-22-0413.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TA-CIN	Vaccine	0.1 mg	Intramuscular
Subject	pNGVL4a-Sig/E7(detox)/HSP70	Vaccine	3 mg	Intramuscular