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COMPLETED Phase 2

Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

NCT00339040 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.

Interventions

  • BIOLOGICAL Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
  • OTHER Placebo/QHPV

Study Locations (20)

California

  • Usc La Nichd Crs — Alhambra
  • Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles
  • Children's Hosp. of Orange County — Orange
  • UCSD Mother-Child-Adolescent Program CRS — San Diego
  • Univ. of California San Francisco NICHD CRS — San Francisco

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale
  • Univ. of Florida Jacksonville NICHD CRS — Jacksonville
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami

Illinois

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago
  • Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago
  • Chicago Children's CRS — Chicago

Massachusetts

  • Children's Hosp. of Boston NICHD CRS — Boston
  • Boston Medical Center Ped. HIV Program NICHD CRS — Boston
  • WNE Maternal Pediatric Adolescent AIDS CRS — Worcester

District of Columbia

  • Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C.
  • Howard Univ. Washington DC NICHD CRS — Washington D.C.

Colorado

  • Univ. of Colorado Denver NICHD CRS — Aurora

Connecticut

  • Connecticut Children's Med. Ctr. — Hartford

Louisiana

  • Children's Hosp. — New Orleans

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2006-10
Est. Completion 2009-08
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00339040

The ClinicalTrials.gov registry entry for NCT00339040 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions — of which Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00339040 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00339040 about?

NCT00339040 is a clinical study titled "Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children". The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.

What is the current status of trial NCT00339040?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2006-10. Estimated completion is 2009-08.

What conditions does trial NCT00339040 study?

This clinical trial studies the following conditions: HIV Infections, Sexually Transmitted Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00339040?

The interventions under investigation include: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) (BIOLOGICAL), Placebo/QHPV (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00339040?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00339040 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial