Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
HIV Infections, Influenza
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring FluMist, Influenza Vaccine, Adolescent, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: HIV infected Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated Meet certain CD4 cell count and CD4% requirements Viral load of less than 60,000 copies/ml within 60 days prior to study start Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years Written informed consent of parent or legal guardian Availability of parent or legal guardian to be contacted by phone Exclusion Criteria: Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization History of hypersensitivity to any component of IAIV or FluMist History of Guillain-Barre syndrome Receipt of any inactivated vaccine within 14 days prior to the study vaccination Receipt of any live vaccine within 30 days prior to the study vaccination Plans to receive any vaccine within the 30 days following the vaccination Receipt of any additional influenza vaccine for the duration of the study Prophylactic use of drugs with anti-influenza activity Moderate chronic pulmonary disease, obstructive or restrictive Cardiopulmonary disease affecting normal childhood activity Medically-diagnosed wheezing, bronchodilator use, or steroid use within the past 42 days Medical illness associated with suppression of T-cell immunity Pregnancy, breast-feeding, or unwillingness to use acceptable methods of contraception for 3 months following vaccination Severely immunosuppressed household member Receipt of any blood products within 3 months prior to vaccination or expected receipt during the study, including the 6-month follow-up period Significant fever or illness within 72 hours prior to vaccination Any other condition that would interfere with the study
Sites / Locations
- UAB, Dept. of Ped., Div. of Infectious Diseases
- Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
- Phoenix Children's Hosp.
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Usc La Nichd Crs
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- Children's Hosp. of Orange County
- UCSD Maternal, Child, and Adolescent HIV CRS
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Colorado Denver NICHD CRS
- Connecticut Children's Med. Ctr.
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Children's National Med. Ctr. Washington DC NICHD CRS
- Children's National Med. Ctr., ACTU
- Howard Univ. Washington DC NICHD CRS
- South Florida CDC Ft Lauderdale NICHD CRS
- Children's Diagnostic & Treatment Ctr. of South Florida
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- USF - Tampa NICHD CRS
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Columbus Regional HealthCare System, The Med. Ctr.
- Chicago Children's CRS
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Lawrence Family Health Ctr., Essex St. Clinic
- Lowell Community Health Ctr.
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Children's Hospital of Michigan NICHD CRS
- Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
- NJ Med. School CRS
- Bronx-Lebanon Hosp. IMPAACT CRS
- Jacobi Med. Ctr. Bronx NICHD CRS
- Jacobi Med. Ctr.
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- Nyu Ny Nichd Crs
- Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
- Harlem Hosp. Ctr. NY NICHD CRS
- Columbia IMPAACT CRS
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- St. Jude/UTHSC CRS
- Texas Children's Hosp. CRS
- Children's Hosp. of the King's Daughters, Infectious Disease
- Seattle Children's Hospital CRS
- UW School of Medicine - CHRMC
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS