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NCT01086657 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...
A Phase 1 study of Influenza A Virus, H5N1 Subtype, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT01086657: Completed Phase 1 study of Influenza A Virus, H5N1 Subtype, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01086657 is a Phase 1 study of Influenza A Virus, H5N1 Subtype that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086657, a Phase 1 study of Influenza A Virus, H5N1 Subtype, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- New vaccines against avian influenza, also known as "bird flu," are being developed and require testing to determine if they are safe and effective and whether they have any side effects. Researchers are interested in testing two experimental avian influenza vaccines to see whether they are safe, if there are any side effects from the vaccines, and how the body's immune response differs in response to different vaccination schedules. One vaccine is an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that allows the body to use vaccine to make an immune system response to a specific part of an avian influenza protein. Objectives: * To determine the safety and potential side effects of two experimental vaccines against avian influenza. * To evaluate whether the time between the two experimental vaccine injections affects the immune response to the vaccine. Eligibility: \- Healthy individuals between 18 and 60 years of age. Design: * Participants will be randomly divided (by chance) into six groups to receive two injections of vaccine at different intervals. One group will receive only the inactivated vaccine, while the other groups will receive the DNA vaccine followed by the inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks or 24 weeks later). * Participants will remain at the clinical center for at least 30 minutes after each vaccination. A few days after each injection, participants will contact staff by telephone or have a clinic visit. Participants will also be asked to complete a diary card at home for 5 days to keep track of temperature changes, injection site skin changes, and other effects. * Four weeks after the first injection, participants will return for a clinic visit and to provide blood samples for testing. * Two weeks after the second injection, participants will return for a clinic visit and provide blood samples (collected through apheresis) to provide in
Conditions Studied
Interventions
- BIOLOGICAL VRC-AVIDNA036-00-VP
- BIOLOGICAL Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-02-25 |
| Est. Completion | 2011-12-12 |
| Phase | Phase 1 |
What the finished NCT01086657 record still lists
NCT01086657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Influenza A Virus, H5N1 Subtype appearing as the primary indexed condition, and to 2 interventions - of which VRC-AVIDNA036-00-VP is the first listed.
NCT01086657 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01086657 about?
NCT01086657 is a clinical study titled "An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...". Background: \- New vaccines against avian influenza, also known as "bird flu," are being developed and require testing to determine if they are safe and effective and whether they have any side effects. Researchers are interested in testing two experimental avian influenza vaccines to see whether t...
What is the current status of trial NCT01086657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2010-02-25. Estimated completion is 2011-12-12.
What conditions does trial NCT01086657 study?
This clinical trial studies the following conditions: Influenza A Virus, H5N1 Subtype.
What interventions are being tested in trial NCT01086657?
The interventions under investigation include: VRC-AVIDNA036-00-VP (BIOLOGICAL), Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01086657?
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 NCT01086657 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086657's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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