Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
- Conditions
- InfluenzaHIV Infections
- Registration Number
- NCT00091702
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
🇺🇸Chicago, Illinois, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
Seattle Children's Hospital CRS
🇺🇸Seattle, Washington, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Connecticut Children's Med. Ctr.
🇺🇸Hartford, Connecticut, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Phoenix Children's Hosp.
🇺🇸Phoenix, Arizona, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
South Florida CDC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
Columbus Regional HealthCare System, The Med. Ctr.
🇺🇸Columbus, Georgia, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Lowell Community Health Ctr.
🇺🇸Lowell, Massachusetts, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
Jacobi Med. Ctr.
🇺🇸Bronx, New York, United States
Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
🇺🇸Saint Louis, Missouri, United States
Jacobi Med. Ctr. Bronx NICHD CRS
🇺🇸Bronx, New York, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Children's Hosp. of the King's Daughters, Infectious Disease
🇺🇸Norfolk, Virginia, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
UAB, Dept. of Ped., Div. of Infectious Diseases
🇺🇸Birmingham, Alabama, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
🇺🇸New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
Children's Diagnostic & Treatment Ctr. of South Florida
🇺🇸Fort Lauderdale, Florida, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Augusta, Georgia, United States
Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
🇺🇸Mobile, Alabama, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Children's Hosp. of Orange County
🇺🇸Orange, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Children's National Med. Ctr. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
🇺🇸Gainesville, Florida, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Lawrence Family Health Ctr., Essex St. Clinic
🇺🇸Lawrence, Massachusetts, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States