Study of Treatment for HPV16+ ASC-US or LSIL

Conditions

• ASC-US
• LSIL

Eligibility Criteria

Sex

FEMALE

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• pNGVL4aCRTE6E7L2 — BIOLOGICAL
  Naked pNGVL4aCRTE6E7L2 DNA plasmid
• TA-CIN — BIOLOGICAL
  TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.

Study Details

Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Key Dates

Start date

Jul 10, 2023

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: pNGVL4aCRTE6E7L2 0.3mg dose
  Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
• Experimental: pNGVL4aCRTE6E7L2 1 mg dose
  Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
• Experimental: pNGVL4aCRTE6E7L2 3 mg dose
  High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
• Experimental: PVX-6
  Selected dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0 and 4, and the TA-CIN protein is administered by intramuscular injection at week 8.

Primary Outcome Measure

Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination [ Time Frame: 12 months ]

Central Contacts

• Wendy Wu, MS
  +886 2 8226 8451
  [email protected]
• Yung-Nien Chang, Ph.D.
  410-804-9662
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL