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

28 oktober 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning

300

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbetspartners

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

Utredare

  • Studiestol: Myron J. Levin, MD, University of Colorado, Denver

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Avslutad studie (Faktisk)

1 januari 2006

Studieregistreringsdatum

Först inskickad

16 september 2004

Först inskickad som uppfyllde QC-kriterierna

17 september 2004

Första postat (Uppskatta)

20 september 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P1057
  • 10612 (Annan identifierare: CTEP)
  • PACTG P1057

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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