Immunogenicity of Inactivated Swine H1N1 Vaccine In HIV Infected Children - The Miami Cohort Study
Public ClinicalTrials.gov record NCT02031874. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02031874
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 6 Months to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2009
- Primary completion
- Aug 31, 2010
- Completion
- Nov 30, 2012
- Last update posted
- Apr 23, 2014
2009 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02031874, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2014 · Synced Sep 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02031874 live on ClinicalTrials.gov.