Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
28 de octubre de 2021 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)
A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción
300
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- UAB, Dept. of Ped., Div. of Infectious Diseases
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Mobile, Alabama, Estados Unidos
- Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Phoenix Children's Hosp.
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California
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Long Beach, California, Estados Unidos, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles, California, Estados Unidos, 90033
- Usc La Nichd Crs
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Los Angeles, California, Estados Unidos
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
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Oakland, California, Estados Unidos, 94609-1809
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
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Orange, California, Estados Unidos, 92868
- Children's Hosp. of Orange County
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San Diego, California, Estados Unidos, 92103
- UCSD Maternal, Child, and Adolescent HIV CRS
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San Francisco, California, Estados Unidos, 94143-0105
- UCSF Pediatric AIDS CRS
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Torrance, California, Estados Unidos, 90509
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
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Colorado
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Aurora, Colorado, Estados Unidos
- Univ. of Colorado Denver NICHD CRS
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Connecticut
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Hartford, Connecticut, Estados Unidos
- Connecticut Children's Med. Ctr.
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New Haven, Connecticut, Estados Unidos, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Children's National Med. Ctr., ACTU
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Washington, District of Columbia, Estados Unidos, 20060
- Howard Univ. Washington DC NICHD CRS
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Washington, District of Columbia, Estados Unidos, 20010
- Children's National Med. Ctr. Washington DC NICHD CRS
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- South Florida CDC Ft Lauderdale NICHD CRS
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Fort Lauderdale, Florida, Estados Unidos
- Children's Diagnostic & Treatment Ctr. of South Florida
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Gainesville, Florida, Estados Unidos, 32610-0296
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
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Jacksonville, Florida, Estados Unidos, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Miami, Florida, Estados Unidos, 33136
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Tampa, Florida, Estados Unidos, 33620
- USF - Tampa NICHD CRS
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Georgia
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Augusta, Georgia, Estados Unidos
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
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Columbus, Georgia, Estados Unidos, 31901
- Columbus Regional HealthCare System, The Med. Ctr.
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Chicago Children's CRS
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Chicago, Illinois, Estados Unidos
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
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Chicago, Illinois, Estados Unidos
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112-2699
- Tulane/LSU Maternal/Child CRS
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Maryland
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Baltimore, Maryland, Estados Unidos
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
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Baltimore, Maryland, Estados Unidos
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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Boston, Massachusetts, Estados Unidos, 02118
- BMC, Div. of Ped Infectious Diseases
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Lawrence, Massachusetts, Estados Unidos, 01841-2884
- Lawrence Family Health Ctr., Essex St. Clinic
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Lowell, Massachusetts, Estados Unidos, 01854
- Lowell Community Health Ctr.
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Health, Baystate Med. Ctr.
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Worcester, Massachusetts, Estados Unidos
- WNE Maternal Pediatric Adolescent AIDS CRS
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan NICHD CRS
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
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New Jersey
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Newark, New Jersey, Estados Unidos
- NJ Med. School CRS
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New York
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Bronx, New York, Estados Unidos, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
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Bronx, New York, Estados Unidos, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS
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Bronx, New York, Estados Unidos, 10461
- Jacobi Med. Ctr.
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Brooklyn, New York, Estados Unidos, 11203-2098
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
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New York, New York, Estados Unidos, 10016
- Nyu Ny Nichd Crs
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New York, New York, Estados Unidos, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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New York, New York, Estados Unidos
- Columbia IMPAACT CRS
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New York, New York, Estados Unidos, 10029
- Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
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Rochester, New York, Estados Unidos, 14642
- Strong Memorial Hospital Rochester NY NICHD CRS
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Stony Brook, New York, Estados Unidos, 11794-8111
- SUNY Stony Brook NICHD CRS
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7220
- UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
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Durham, North Carolina, Estados Unidos, 27705
- DUMC Ped. CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4318
- The Children's Hosp. of Philadelphia IMPAACT CRS
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105-2794
- St. Jude/UTHSC CRS
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Texas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hosp. CRS
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Children's Hosp. of the King's Daughters, Infectious Disease
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Washington
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Seattle, Washington, Estados Unidos, 98105
- UW School of Medicine - CHRMC
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Seattle, Washington, Estados Unidos, 98105-0371
- Seattle Children's Hospital CRS
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San Juan, Puerto Rico
- San Juan City Hosp. PR NICHD CRS
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San Juan, Puerto Rico, 00936-5067
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
5 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Silla de estudio: Myron J. Levin, MD, University of Colorado, Denver
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Finalización del estudio (Actual)
1 de enero de 2006
Fechas de registro del estudio
Enviado por primera vez
16 de septiembre de 2004
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2004
Publicado por primera vez (Estimar)
20 de septiembre de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P1057
- 10612 (Otro identificador: CTEP)
- PACTG P1057
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .