Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

28. oktober 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

300

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studieafslutning (Faktiske)

1. januar 2006

Datoer for studieregistrering

Først indsendt

16. september 2004

Først indsendt, der opfyldte QC-kriterier

17. september 2004

Først opslået (Skøn)

20. september 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P1057
  • 10612 (Anden identifikator: CTEP)
  • PACTG P1057

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Norway

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner