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Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL

NCT01928225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-06-24

Study results available
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Summary

Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors. This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.

Conditions

  • Cervical High Grade Squamous Intraepithelial Lesion

Interventions

BIOLOGICAL

Human Papillomavirus vaccine

The participants receive the qHPV vaccine at entry, week 4 and week 26

Sponsors & Collaborators

Principal Investigators

  • Timothy J Wilkin, M.D. MPH · Weill Medical College of Cornell University

  • Cynthia Firnhaber, M.D. · University or Witswatersrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2017-11-30
Completion
2018-03-01

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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 NCT01928225 on ClinicalTrials.gov