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NCT00459316 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

A Phase 1 study of HIV Infections and Meningitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
384
Enrollment target
20
Study locations

NCT00459316: Completed Phase 1 study of HIV Infections and Meningitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00459316 is a Phase 1 study of HIV Infections and Meningitis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 384 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00459316, a Phase 1 study of HIV Infections and Meningitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
384 participants
Enrollment target
20
Study locations

Study Summary

Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especially for HIV-infected youth who have weakened immune systems. The purpose of this study was to determine the safety of and immune response to a preventive meningitis vaccine in HIV-infected youth.

Primary Outcome

Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.

Conditions Studied

HIV Infections Meningitis

Interventions

  • BIOLOGICAL Quadrivalent meningococcal conjugate vaccine

Study Locations (20)

California

  • Usc La Nichd Crs - Alhambra
  • Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
  • Children's Hospital of Los Angeles NICHD CRS - Los Angeles
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
  • University of California, UC San Diego CRS - San Diego
  • Univ. of California San Francisco NICHD CRS - San Francisco
  • Harbor UCLA Medical Ctr. NICHD CRS - Torrance

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville
  • Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami
  • USF - Tampa NICHD CRS - Tampa

District of Columbia

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

Illinois

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
  • Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS - Chicago

Massachusetts

  • Children's Hosp. of Boston NICHD CRS - Boston
  • Boston Medical Center Ped. HIV Program NICHD CRS - Boston

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Louisiana

  • Tulane Univ. New Orleans NICHD CRS - New Orleans

Maryland

  • Univ. of Maryland Baltimore NICHD CRS - Baltimore

Trial Details

FieldValue
Enrollment Target 384 participants
Start Date 2007-06
Est. Completion 2013-03
Phase Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00459316 record still lists

NCT00459316 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (14% lower).

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Quadrivalent meningococcal conjugate vaccine is the first listed.

NCT00459316 names 20 study sites across 8 states, led by California, Florida, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00459316 about?

NCT00459316 is a clinical study titled "Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth". Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especi...

What is the current status of trial NCT00459316?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 384 participants. The study started on 2007-06. Estimated completion is 2013-03.

What conditions does trial NCT00459316 study?

This clinical trial studies the following conditions: HIV Infections, Meningitis.

What interventions are being tested in trial NCT00459316?

The interventions under investigation include: Quadrivalent meningococcal conjugate vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00459316?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00459316 being conducted?

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

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00459316's enrollment target sits among peer trials

384 88th of 542 higher than 455 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00459316, the US trial registry maintained by the National Library of Medicine. NCT00459316 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.