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NCT00992433 · ClinicalTrials.gov registry record · Phase 2
H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT00992433: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00992433 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 192 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00992433, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Interventions
- BIOLOGICAL Inactivated Influenza H1N1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00992433 record still lists
NCT00992433 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 1 intervention - of which Inactivated Influenza H1N1 vaccine is the first listed.
NCT00992433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00992433 about?
NCT00992433 is a clinical study titled "H1N1 Vaccine at Two Dose Levels in HIV Positive Adults". 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 st...
What is the current status of trial NCT00992433?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2009-11. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00992433?
The interventions under investigation include: Inactivated Influenza H1N1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00992433?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00992433's enrollment target sits among peer trials
192 352nd of 2000 higher than 1,648 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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