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

NCT03911076 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-06-17

No results posted yet for this study

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

Conditions

  • ASC-US
  • ASC-H
  • LSIL

Interventions

BIOLOGICAL

PVX-2

pNGVL4a-Sig/E7(detox)/HSP70 (pBI-1, naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)

OTHER

Placebo

PBS and PGC

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • PapiVax Biotech, Inc.

    lead OTHER

Principal Investigators

  • Mark Einstein, MD, MS · Professor and Chairman, Dept. of OBS&GYN, Rutgers New Jersey Medical School, Newark, NJ 07101

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2022-06-08
Completion
2022-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911076 on ClinicalTrials.gov