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Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

NCT01209325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2020-08-11

Study results available
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Summary

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection.

PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.

Conditions

  • Anal Cancer
  • Nonneoplastic Condition
  • Penile Cancer
  • Precancerous Condition

Interventions

BIOLOGICAL

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

OTHER

laboratory biomarker analysis

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of Arkansas

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • AIDS and Cancer Specimen Resource

    collaborator OTHER

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Joel Palefsky, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
26 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-28
Primary Completion
2017-12-12
Completion
2017-12-12
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
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 NCT01209325 on ClinicalTrials.gov