Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
NCT ID: NCT00091702
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
300 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
Interventions
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Cold-adapted live attenuated influenza vaccine (FluMist)
Inactivated influenza vaccine (IAIV)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Myron J. Levin, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States
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
Chicago Children's CRS
Chicago, Illinois, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Lawrence Family Health Ctr., Essex St. Clinic
Lawrence, Massachusetts, United States
Lowell Community Health Ctr.
Lowell, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
St Louis, Missouri, United States
NJ Med. School CRS
Newark, New Jersey, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
Nyu Ny Nichd Crs
New York, 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
Columbia IMPAACT CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States
Jacobi Med. Ctr.
The Bronx, 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
DUMC Ped. CRS
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
Children's Hosp. of the King's Daughters, Infectious Disease
Norfolk, Virginia, United States
Seattle Children's Hospital CRS
Seattle, Washington, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Gunthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31. doi: 10.1086/315260.
Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998 May 14;338(20):1405-12. doi: 10.1056/NEJM199805143382002.
King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, Newman F, Belshe RB, Kovacs A, Deville JG, Jelonek M; HIV Influenza Study Group. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J. 2001 Dec;20(12):1124-31. doi: 10.1097/00006454-200112000-00006.
King JC Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, Lambert JS, Belshe RB. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000 Feb;181(2):725-8. doi: 10.1086/315246.
Weinberg A, Song LY, Walker R, Allende M, Fenton T, Patterson-Bartlett J, Nachman S, Kemble G, Yi TT, Defechereux P, Wara D, Read JS, Levin M; IMPAACT P1057 Team. Anti-influenza serum and mucosal antibody responses after administration of live attenuated or inactivated influenza vaccines to HIV-infected children. J Acquir Immune Defic Syndr. 2010 Oct;55(2):189-96. doi: 10.1097/QAI.0b013e3181e46308.
Other Identifiers
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10612
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1057
Identifier Type: -
Identifier Source: secondary_id
P1057
Identifier Type: -
Identifier Source: org_study_id