Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth
Condition: HIV-1 Infection; H1N1; Influenza; Flu
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): FluMist; Fluvirin; Fluzone
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered at the manufacture's recommended dose; Vaccine administered at the manufacturer's recommended dose.; Vaccine administered at manufacturer's recommended dose
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-1 perinatally infected children and youth 6 months to 25 years of age.

        For inclusion into the study, if perinatal acquisition of HIV infection cannot be confirmed
        based on the child's medical record, it is acceptable to enroll the child if the
        investigator's assessment is that the most likely route of infection was perinatal.
      
Keywords: Influenza; Perinatal; immunogenicity; Monovalent vaccine; Children; Youth; H1N1; Adolescent; Flu