The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.

Condition	Treatment or Intervention	Phase
HIV Infections Influenza	Vaccine: Cold-adapted live attenuated influenza vaccine (FluMist)  Vaccine: Inactivated influenza vaccine (IAIV)	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  300

Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respiratory illnesses and bacterial infections. HIV infected children may have an increased risk for developing influenza-related bacterial complications, and influenza infections among this population may lead to more rapid disease progression. The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately, FluMist is associated with viral shedding, a period of time when the influenza virus used to produce the vaccine may be transmitted to other people. This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination.

Participants in this study will be randomly assigned to one of two arms. Arm A participants will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A physical exam will be performed at the initial study visit; blood will be collected at study start and at each visit thereafter. Phone calls will be made to participants throughout the study. All participants will have a final study visit after 6 months.

Ages Eligible for Study:  5 Years   -   17 Years,  Genders Eligible for Study:  Both

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

Alabama
      University of South Alabama, Mobile,  Alabama,  United States
      University of Alabama at Birmingham (Pediatric), Birmingham,  Alabama,  35233,  United States
Arizona
      Phoenix Childrens Hospital, Phoenix,  Arizona,  85006,  United States
California
      Childrens Hospital, Oakland (Pediatric), Oakland,  California,  94609-1809,  United States
      Childrens Hospital of Orange County, Orange,  California,  92868,  United States
      UCSF, Moffitt Hospital (Pediatric), San Francisco,  California,  94143-0105,  United States
      UCSD Mother, Child & Adolescent HIV Program, San Diego,  California,  92103,  United States
      Harbor-UCLA Medical Center, Torrance,  California,  90509,  United States
      Los Angeles County Medical Center/USC, Los Angeles,  California,  90033,  United States
      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States
      UCLA Medical Center (Pediatric), Los Angeles,  California,  90095-1752,  United States
Colorado
      Childrens Hospital (U. Colorado, Denver), Denver,  Colorado,  80218-1088,  United States
Connecticut
      Connecticut Childrens Medical Center (Pediatric), Farmington,  Connecticut,  06030-3805,  United States
      Yale University School of Medicine, New Haven,  Connecticut,  06504,  United States
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010,  United States
      Howard University Hospital, Washington,  District of Columbia,  20060,  United States
Florida
      University of Florida - Health Science Center, Jacksonville,  Florida,  32209,  United States
      University of Florida, Gainesville, Gainesville,  Florida,  32610-0296,  United States
      North Broward Hospital District, Fort Lauderdale,  Florida,  33316,  United States
      University of Miami (Pediatric), Miami,  Florida,  33136,  United States
      University of South Flordia, St. Petersburg,  Florida,  33701,  United States
Georgia
      The Medical Center, Columbus,  Georgia,  31901,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Chicago Childrens Memorial Hospital (Pediatric), Chicago,  Illinois,  60614,  United States
      Womens & Childrens HIV Program, Chicago,  Illinois,  60608-1797,  United States
      The University of Chicago Childrens Hospital, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ., Charity Hospital of New Orleans, New Orleans,  Louisiana,  70112-2699,  United States
Maryland
      University of Maryland (Pediatric), Baltimore,  Maryland,  21201,  United States
      Johns Hopkins University (Pediatric), Baltimore,  Maryland,  United States
Massachusetts
      Childrens Hospital of Boston, Boston,  Massachusetts,  02115,  United States
      Baystate Medical Center, Springfield, Springfield,  Massachusetts,  01199,  United States
      University of Massachusetts Medical School, Worcester,  Massachusetts,  01655-0001,  United States
      Lowell Community Health Center, Lawrence,  Massachusetts,  01841-2884,  United States
      Lawrence Family Health Center, Lawrence,  Massachusetts,  01841-2884,  United States
      Boston Medical Center (Pediatric), Boston,  Massachusetts,  02118,  United States
Michigan
      Childrens Hospital of Michigan, Detroit,  Michigan,  48201,  United States
Missouri
      St. Louis Children's Hospital, St. Louis,  Missouri,  63110,  United States
New Jersey
      Univ. of Med. & Dentistry of NJ/Univ. Hospital, Newark,  New Jersey,  07101-1709,  United States
New York
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642-0001,  United States
      Jacobi Medical Center, Bronx,  New York,  10461,  United States
      Bronx Lebanon Hospital Center, Bronx,  New York,  10457,  United States
      Harlem Hospital, New York,  New York,  10037,  United States
      State University of New York at Stony Brook, Stony Brook,  New York,  11794-8111,  United States
      Children's Hospital at Downstate, Brooklyn,  New York,  11203-2098,  United States
      New York University School of Medicine, New York,  New York,  10016,  United States
      The Columbia Presbyterian Medical Center, New York,  New York,  United States
North Carolina
      Duke University, Durham,  North Carolina,  27705,  United States
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7220,  United States
Pennsylvania
      Childrens Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104-4318,  United States
Tennessee
      St. Jude Childrens Research Hospital, Memphis, Memphis,  Tennessee,  38105-2794,  United States
Texas
      Baylor (Texas Childrens Hospital) (Pediatric), Houston,  Texas,  77030,  United States
      Childrens Medical Center of Dallas, Dallas,  Texas,  75235,  United States
Virginia
      Children's Hospital of the King's Daughters, Norfolk,  Virginia,  23507,  United States
Washington
      Mt. Sinai Medical Center, Seattle,  Washington,  98105-0371,  United States
      Children's Hospital and Regional Medical Center/SE, Seattle,  Washington,  98105-0371,  United States
Puerto Rico
      San Juan City Hospital, San Juan,  Puerto Rico
      Univ. of Puerto Rico, U. Childrens Hospital AIDS, San Juan,  00936-5067,  Puerto Rico

Study chairs or principal investigators

Myron J. Levin, MD,  Study Chair,  University of Colorado   

Study ID Numbers:  PACTG P1057
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  September 16, 2004
ClinicalTrials.gov Identifier:  NCT00091702
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08