Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections, Influenza

In brief

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.

Key facts

Study ID

NCT00091702

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Expected to finish

2006-01-01

Last updated by the study team

2021-11-01

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ. of South Alabama College of Medicine, Southeast Ped. ACTU — Mobile, Alabama, United States
• Phoenix Children's Hosp. — Phoenix, Arizona, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• Children's Hosp. of Orange County — Orange, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Connecticut Children's Med. Ctr. — Hartford, Connecticut, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• South Florida CDC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Children's Diagnostic & Treatment Ctr. of South Florida — Fort Lauderdale, Florida, 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
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• USF - Tampa NICHD CRS — Tampa, Florida, United States
• Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Augusta, Georgia, United States
• Columbus Regional HealthCare System, The Med. Ctr. — Columbus, Georgia, United States
• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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