PVX-2

Research Pre-Clinical Phase I Phase II Phase III

持續性感染

Phase II Study of Treatment for Persistent Infection With HPV-16 (PVX-2)

A Randomized Double-Blind, Placebo-controlled Phase II Trial with Safety Run-In of intramuscular pNGVL4a-Sig/E7(detox)/HSP70 and TA-CIN.

Safety Run-In Phase

Safety study
Human Immunodeficiency Virus (HIV)-seronegative
Treatment dose: pNGVL4a-sig/E7(detox)/HSP70 (3 mg) twice, followed by one dose of TA-CIN (0.10 mg)
Schedule for administration: IM vaccination at weeks 0, 4, and 8
Primary safety analysis to be conducted at Week 12
Primary analyses to be conducted at Month 6

Randomized Phase II:

Randomized double blind, placebo-controlled Trial
HIV-seronegative
Active Arm: pNGVL4a-sig/E7(detox)/HSP70 DNA(3 mg) twice followed by one dose of TA-CIN (0.10 mg)
Placebo Arm: Phosphate buffered saline (PBS)/PBS/Phosphate Glycine Cysteine (PGC) buffer
Schedule for administration: IM vaccination at weeks 0, 4, and 8
Primary analyses to be conducted at Month 6