Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Quadrivalent Live Attenuated Influenza Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 101.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Shedding; Immunogenicity; Safety; HIV infected; Children; Young adults

Summary:

      The goal of this study is to determine if there is a difference in shedding (primary
      objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and
      HIV-negative children and young adults who are receiving the quadrivalent live-attenuated
      influenza vaccine (QLAIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2-25

          -  Only supposed to get one dose of vaccine for upcoming influenza season

          -  No viral respiratory symptoms at time of immunization

          -  HIV-infected group: must have:

               -  HIV-infection documented by 2 tests such as positive serology, positive HIV DNA
                  or positive HIV RNA;

               -  must thave a CD4>25% or 500, or

               -  must have CD4>15% or 200 and be on HAART

          -  Healthy controls: no major medical problems affecting the immune system

          -  Recruited among:

               -  HIV-unifected clients of the Children's Immunodeficiency Program(CHIP),

               -  Children's Hospital Colorado Child Health Clinic and Adolescent Clinics.

        Exclusion Criteria:

          -  History of:

               -  reactive airway disease,

               -  recurrent wheezing, or

               -  asthma

          -  Active wheezing at time of immunization

          -  On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir,
             oseltamivir) at time of immunization or planned over 21 days of shedding collection

          -  Receipt of IVIG within 3 months prior to enrollment

          -  Plan to receive IVIG during the 4 weeks after immunization

          -  Moderate to severely immunocompromised individual living in the home

          -  Pregnant

          -  Breastfeeding

          -  Plan to start immunosupressive medications or stop HAART over the 4 weeks following
             immmunization

          -  Temperature > 100F or 37.8C

          -  Rhinorrhea or cough not related to allergies at the time of immunization

          -  History of fungal sinusitis

          -  History of Guillain-Barre Syndrome

          -  Current on antibiotics

          -  Currently taking aspirin

          -  On an investigational drug at the time of immunization or planned over the 28 days of
             shedding collection

          -  On any experimental medication at time of immunization or planned over 21 days of
             shedding collection