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Preparedness Study - HPV Vaccine

NCT01489527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2015-02-06

Study results available
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Summary

Moffitt Cancer Center is the Coordinating Center for this study.

The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.

The specific aims of this study are to:

1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 \[Gardasil\]) or placebo vaccine.
2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
3. Assess the rate of compliance through the 3-dose vaccination series

Conditions

  • Sexual Transmission of Infection

Interventions

BIOLOGICAL

Gardasil Vaccine

The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.

OTHER

Placebo

The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.

Sponsors & Collaborators

Principal Investigators

  • Anna Giuliano, Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-04-30
Completion
2014-12-31

Countries

  • United States
  • South Africa

Study Locations

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Entities

Companies

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 NCT01489527 on ClinicalTrials.gov