The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body. HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
HIV-infected children typically respond poorer to vaccines as compared to normal children. The FDA has currently approved several Influenza A 2009 monovalent vaccines to be used in children and adults. However, little data is available in perinatally infected youth. Therefore, knowledge of the immunogenicity of several of the licensed Influenza A 2009 monovalent vaccines in HIV-infected children and youth is critically important to address the health care needs of this vulnerable population. Efforts are currently underway to evaluate Influenza A 2009 monovalent vaccines in healthy children as well as other populations. This study will assess the immune response following receipt of three Influenza A monovalent vaccines in HIV-1 infected children and youth. Protection of HIV-1 infected children and youth from 2009 H1N1 Influenza A will require knowledge of immunogenicity of these new products in this population. The 2009 (H1N1) Influenza A virus is likely to infect a significant proportion of HIV-1 infected children and youth. Immunogenicity of licensed and commercially available Influenza A 2009 monovalent vaccines must be established in HIV-1 infected children in order to assure that this population is protected. Lack of a protective immune response would support the need for additional measures to protect this high risk population.
Study Type
OBSERVATIONAL
Enrollment
149
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States
USC/Los Angeles County Medical Center NICHD CRS
Los Angeles, California, United States
University of California San Francisco NICHD CRS (5091)
San Francisco, California, United States
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, United States
University of South Florida Tampa (5018)
Tampa, Florida, United States
Chicago Children's CRS (4001)
Chicago, Illinois, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
...and 7 more locations
The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years.
Time frame: 8 months
The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age.
Time frame: 8 months
The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age.
Time frame: 8 months
Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine.
Time frame: 8 months
Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
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