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NCT00383071 · ClinicalTrials.gov registry record · Phase 2
Development of Immune Globulin Treatment for Avian Flu
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT00383071 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 126 participants.
The verdict
NCT00383071, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment. Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination. Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms. In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a cath
Interventions
- PROCEDURE Apheresis
- BIOLOGICAL H5N1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00383071
The ClinicalTrials.gov registry entry for NCT00383071 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 126 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 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Apheresis is the first listed.
NCT00383071 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00383071 about?
NCT00383071 is a clinical study titled "Development of Immune Globulin Treatment for Avian Flu". This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack ...
What is the current status of trial NCT00383071?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2006-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00383071?
The interventions under investigation include: Apheresis (PROCEDURE), H5N1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00383071?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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