HIV Infections Clinical Trial
Official title:
A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
NCT number | NCT00091702 |
Other study ID # | P1057 |
Secondary ID | 10612PACTG P1057 |
Status | Completed |
Phase | Phase 1/Phase 2 |
First received | |
Last updated | |
Est. completion date | January 2006 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | San Juan City Hosp. PR NICHD CRS | San Juan | |
Puerto Rico | Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | San Juan | |
United States | Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Augusta | Georgia |
United States | Univ. of Colorado Denver NICHD CRS | Aurora | Colorado |
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 | UAB, Dept. of Ped., Div. of Infectious Diseases | Birmingham | Alabama |
United States | BMC, Div. of Ped Infectious Diseases | Boston | Massachusetts |
United States | HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts |
United States | Bronx-Lebanon Hosp. IMPAACT CRS | Bronx | New York |
United States | Jacobi Med. Ctr. | Bronx | New York |
United States | Jacobi Med. Ctr. Bronx NICHD CRS | Bronx | New York |
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 | 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 | Columbus Regional HealthCare System, The Med. Ctr. | Columbus | Georgia |
United States | Children's Hospital of Michigan NICHD CRS | Detroit | Michigan |
United States | DUMC Ped. CRS | Durham | North Carolina |
United States | Children's Diagnostic & Treatment Ctr. of South Florida | Fort Lauderdale | Florida |
United States | South Florida CDC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida |
United States | Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy | Gainesville | Florida |
United States | Connecticut Children's Med. Ctr. | Hartford | Connecticut |
United States | Texas Children's Hosp. CRS | Houston | Texas |
United States | Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida |
United States | Lawrence Family Health Ctr., Essex St. Clinic | Lawrence | Massachusetts |
United States | Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach | California |
United States | UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California |
United States | Usc La Nichd Crs | Los Angeles | California |
United States | Lowell Community Health Ctr. | Lowell | Massachusetts |
United States | St. Jude/UTHSC CRS | Memphis | Tennessee |
United States | Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida |
United States | Univ. of South Alabama College of Medicine, Southeast Ped. ACTU | Mobile | Alabama |
United States | Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut |
United States | Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana |
United States | Columbia IMPAACT CRS | New York | New York |
United States | Harlem Hosp. Ctr. 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 | Nyu Ny Nichd Crs | New York | New York |
United States | NJ Med. School CRS | Newark | New Jersey |
United States | Children's Hosp. of the King's Daughters, Infectious Disease | Norfolk | Virginia |
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 | The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hosp. | Phoenix | Arizona |
United States | Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York |
United States | Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp. | Saint Louis | Missouri |
United States | UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California |
United States | UCSF Pediatric AIDS CRS | San Francisco | California |
United States | Seattle Children's Hospital CRS | Seattle | Washington |
United States | UW School of Medicine - CHRMC | Seattle | Washington |
United States | Baystate Health, Baystate Med. Ctr. | Springfield | Massachusetts |
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 | USF - Tampa NICHD CRS | Tampa | Florida |
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 | Children's National Med. Ctr., ACTU | Washington | District of Columbia |
United States | Howard Univ. Washington DC NICHD CRS | Washington | District of Columbia |
United States | WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States, Puerto Rico,
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. — View Citation
Günthard 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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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