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Completed Phase 2 Interventional Results available

H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

ClinicalTrials.gov ID: NCT00992433

Public ClinicalTrials.gov record NCT00992433. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 7:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.

Study identification

NCT ID
NCT00992433
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
192 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2009
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010
Last update posted
May 15, 2012

2009 – 2010

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of Iowa Iowa City Iowa 52242
University of Maryland Baltimore - Institute of Human Virology Baltimore Maryland 21201
Saint Louis University St Louis Missouri 63104
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229-3039
Baylor College of Medicine Houston Texas 77030
University of Washington Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00992433, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 15, 2012 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00992433 live on ClinicalTrials.gov.

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