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

28 ottobre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione

300

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Porto Rico, 00936-5067
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • UAB, Dept. of Ped., Div. of Infectious Diseases
      • Mobile, Alabama, Stati Uniti
        • Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85006
        • Phoenix Children's Hosp.
    • California
      • Long Beach, California, Stati Uniti, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, Stati Uniti, 90033
        • Usc La Nichd Crs
      • Los Angeles, California, Stati Uniti
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland, California, Stati Uniti, 94609-1809
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • Orange, California, Stati Uniti, 92868
        • Children's Hosp. of Orange County
      • San Diego, California, Stati Uniti, 92103
        • UCSD Maternal, Child, and Adolescent HIV CRS
      • San Francisco, California, Stati Uniti, 94143-0105
        • UCSF Pediatric AIDS CRS
      • Torrance, California, Stati Uniti, 90509
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Colorado
      • Aurora, Colorado, Stati Uniti
        • Univ. of Colorado Denver NICHD CRS
    • Connecticut
      • Hartford, Connecticut, Stati Uniti
        • Connecticut Children's Med. Ctr.
      • New Haven, Connecticut, Stati Uniti, 06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
        • Children's National Med. Ctr., ACTU
      • Washington, District of Columbia, Stati Uniti, 20060
        • Howard Univ. Washington DC NICHD CRS
      • Washington, District of Columbia, Stati Uniti, 20010
        • Children's National Med. Ctr. Washington DC NICHD CRS
    • Florida
      • Fort Lauderdale, Florida, Stati Uniti, 33316
        • South Florida CDC Ft Lauderdale NICHD CRS
      • Fort Lauderdale, Florida, Stati Uniti
        • Children's Diagnostic & Treatment Ctr. of South Florida
      • Gainesville, Florida, Stati Uniti, 32610-0296
        • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
      • Jacksonville, Florida, Stati Uniti, 32209
        • Univ. of Florida Jacksonville NICHD CRS
      • Miami, Florida, Stati Uniti, 33136
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
      • Tampa, Florida, Stati Uniti, 33620
        • USF - Tampa NICHD CRS
    • Georgia
      • Augusta, Georgia, Stati Uniti
        • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
      • Columbus, Georgia, Stati Uniti, 31901
        • Columbus Regional HealthCare System, The Med. Ctr.
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60614
        • Chicago Children's CRS
      • Chicago, Illinois, Stati Uniti
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago, Illinois, Stati Uniti
        • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70112-2699
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore, Maryland, Stati Uniti
        • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
      • Baltimore, Maryland, Stati Uniti
        • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston, Massachusetts, Stati Uniti, 02118
        • BMC, Div. of Ped Infectious Diseases
      • Lawrence, Massachusetts, Stati Uniti, 01841-2884
        • Lawrence Family Health Ctr., Essex St. Clinic
      • Lowell, Massachusetts, Stati Uniti, 01854
        • Lowell Community Health Ctr.
      • Springfield, Massachusetts, Stati Uniti, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, Stati Uniti
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Children's Hospital of Michigan NICHD CRS
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
    • New Jersey
      • Newark, New Jersey, Stati Uniti
        • NJ Med. School CRS
    • New York
      • Bronx, New York, Stati Uniti, 10457
        • Bronx-Lebanon Hosp. IMPAACT CRS
      • Bronx, New York, Stati Uniti, 10461
        • Jacobi Med. Ctr. Bronx NICHD CRS
      • Bronx, New York, Stati Uniti, 10461
        • Jacobi Med. Ctr.
      • Brooklyn, New York, Stati Uniti, 11203-2098
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • New York, New York, Stati Uniti, 10016
        • Nyu Ny Nichd Crs
      • New York, New York, Stati Uniti, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, Stati Uniti
        • Columbia IMPAACT CRS
      • New York, New York, Stati Uniti, 10029
        • Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
      • Rochester, New York, Stati Uniti, 14642
        • Strong Memorial Hospital Rochester NY NICHD CRS
      • Stony Brook, New York, Stati Uniti, 11794-8111
        • SUNY Stony Brook NICHD CRS
      • Syracuse, New York, Stati Uniti, 13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7220
        • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
      • Durham, North Carolina, Stati Uniti, 27705
        • DUMC Ped. CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104-4318
        • The Children's Hosp. of Philadelphia IMPAACT CRS
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38105-2794
        • St. Jude/UTHSC CRS
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Texas Children's Hosp. CRS
    • Virginia
      • Norfolk, Virginia, Stati Uniti, 23507
        • Children's Hosp. of the King's Daughters, Infectious Disease
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • UW School of Medicine - CHRMC
      • Seattle, Washington, Stati Uniti, 98105-0371
        • Seattle Children's Hospital CRS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaboratori

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigatori

  • Cattedra di studio: Myron J. Levin, MD, University of Colorado, Denver

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Completamento dello studio (Effettivo)

1 gennaio 2006

Date di iscrizione allo studio

Primo inviato

16 settembre 2004

Primo inviato che soddisfa i criteri di controllo qualità

17 settembre 2004

Primo Inserito (Stima)

20 settembre 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 novembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2021

Ultimo verificato

1 ottobre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P1057
  • 10612 (Altro identificatore: CTEP)
  • PACTG P1057

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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