Immunogenicity of Inactivated Swine H1N1 Vaccine In HIV Infected Children - The Miami Cohort Study

NCT02031874 | Completed

• 2 other identifiers: 200908585P30AI073961
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

H1N1; HIV; Immunogenecity

Outcome Measures

Primary Outcomes (1)

• Determine immunogenecity to vaccine

  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 immunization dosing and schedule in the high and low responders (CD4 counts \>200) by a systems biology approach using gene array and multiparametric immune phenotyping.

  1 month

Secondary Outcomes (1)

• Measure Antibody Response

  6 months

Study Arms (1)

Miami Cohort

Measured vaccine response to H1N1 in HIV perinatally infected children

Eligibility Criteria

• Age: 6 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Perinatally Infected Children

You may qualify if:

• Individuals must have a positive ELISA with confirm with a western blot after 18 months of age or a positive DNA or RNA PCR

You may not qualify if:

• Patients with hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination will be excluded. Pregnant individuals will be excluded from the study at this time. Patients with a previous episode of Guillain-Barré Syndrome (GBS) in relation to a previous influenza vaccination, will also be excluded. Allergic reactions, including anaphylactic shock

Sponsors & Collaborators

• University of Miami: lead
• Vaccine and Gene Therapy Institute, Florida: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Frozen PBMC for future experiments as per results.

Study Officials

• Ivan A Gonzalez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

US (1)