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NCT02031874 · ClinicalTrials.gov registry record
Immunogenicity of Inactivated Swine H1N1 Vaccine In HIV Infected Children - The Miami Cohort Study
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 33
- Enrollment target
NCT02031874: Completed study, sponsored by University of Miami.
NCT02031874 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02031874 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 33 participants
- Enrollment target
Study Summary
Immunosuppressed patients are at increased risk for complications of influenza infection, including secondary pneumonia and are recommended for annual influenza vaccination. Thus, the appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus has added an extra layer of complexity in the immunization regimen in this population. In general, susceptibility to swine H1N1 infection among young population is higher as young adults and children completely lack protective titers. According to the Center for Disease Control (CDC), 70 percent of people hospitalized with H1N1 have been "high risk" cases, including persons 65 years of age or older, or people with compromised immune systems as observed during HIV infection. This has prompted CDC to include HIV infected children to be one of the five groups to be vaccinated with the new H1N1 vaccine (National Center for Immunization). Currently no information exists about the nature of the immune response to the vaccine against H1N1 swine-origin influenza virus (S-OIV) in HIV infected children. It is unknown whether HIV impairs the immunogenicity of the vaccine predisposing this population to infection with S-OIV. Thus, a pilot proposal is being undertaken to study the mechanism of H1N1 vaccine protection in HIV infected children, by investigating the correlation of infection status with seroresponse, duration of response and development of influenza-like illness following vaccine. Additionally we will establish whether we can identify immune signatures by characteristic gene expression patterns correlating with the vaccine immunogenicity that can be predictive of efficacy for "good" and "suboptimal" vaccination regimen. Data generated will be used to initiate a comprehensive study on the immunogenicity of the influenza vaccines in HIV-infected children and youth, which is critically important to address the health care needs of this vulnerable population.
Primary Outcome
The primary objectives of this proposal are: 1. To determine the immunogenicity after each of the two doses of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected children by neutralizing antibody titers, including the durability of response. 2. To determine whether vaccinated subjects are dependent upon T cell help and HIV virus control for intrinsic B cell function by antigen specific ELSIPOT assay. 3. To determine whether we can generate immune signatures related to H1N1 immuni
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-12 |
What the finished NCT02031874 record still lists
NCT02031874 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02031874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02031874 about?
NCT02031874 is a clinical study titled "Immunogenicity of Inactivated Swine H1N1 Vaccine In HIV Infected Children - The Miami Cohort Study". Immunosuppressed patients are at increased risk for complications of influenza infection, including secondary pneumonia and are recommended for annual influenza vaccination. Thus, the appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus has added an extra layer of c...
What is the current status of trial NCT02031874?
This trial is currently completed. The enrollment target is 33 participants. The study started on 2009-12. Estimated completion is 2012-12.
Who is sponsoring clinical trial NCT02031874?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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