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NCT01578317 · ClinicalTrials.gov registry record · Phase 1
Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01578317: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01578317 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 43 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578317, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Adjuvants are substances included in vaccines that stimulate the immune system and increase the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immune responses of people who receive a bird flu vaccine with or without AS03 to better understand how the adjuvant works. This information may help develop better flu vaccines. Objectives: \- To compare the healthy immune system responses to bird flu vaccine with or without the AS03 adjuvant. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * Participants will be screened with a physical exam and medical history. * Participants will be assigned to one of two groups. Each group will have an initial vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the same type of vaccine. One group will have the vaccine with AS03; the other group will have the vaccine without it. * All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay will involve the vaccination, followed by regular and frequent blood draws. Participants will be monitored for any signs or symptoms that may be caused by the vaccine. * Additional blood samples will be collected 7, 28, 42, and 100 days after the initial vaccination.
Primary Outcome
Flu Antibody titers at days 0, 21, 42, 100. Antibody-neutralization titers by microneutralization were measured against five different H5N1 virus strains (i.e., A/Vietnam/1194/2004 (clade 1), A/Indonesia/5/2005 (clade 2.1), A/Turkey/15/2006 (clade 2.2), A/Egypt/3072/2010 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4)) at day 0 (prevaccination), day 21 (post first vaccination), day 42 (post second vaccination) and day 100 postvaccination for AS03-adjuvanted group and unadjuvanted group. Sera were
Conditions Studied
Interventions
- BIOLOGICAL H5N1 vaccine plus AS03 adjuvant
- BIOLOGICAL H5N1 vaccine without adjuvant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-03-20 |
| Est. Completion | 2016-01-31 |
| Phase | Phase 1 |
What the finished NCT01578317 record still lists
NCT01578317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which H5N1 vaccine plus AS03 adjuvant is the first listed.
NCT01578317 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01578317 about?
NCT01578317 is a clinical study titled "Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant". Background: \- Adjuvants are substances included in vaccines that stimulate the immune system and increase the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immun...
What is the current status of trial NCT01578317?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-03-20. Estimated completion is 2016-01-31.
What conditions does trial NCT01578317 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01578317?
The interventions under investigation include: H5N1 vaccine plus AS03 adjuvant (BIOLOGICAL), H5N1 vaccine without adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01578317?
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 NCT01578317 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
Similar trials for Influenza
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 NCT01578317's enrollment target sits among peer trials
43 134th of 156 higher than 23 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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