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

28 oktober 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving

300

Fase

Fase 2
Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

5 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Preventie
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

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

Onderzoekers

Studie stoel: Myron J. Levin, MD, University of Colorado, Denver

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie voltooiing (Werkelijk)

1 januari 2006

Studieregistratiedata

Eerst ingediend

16 september 2004

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2004

Eerst geplaatst (Schatting)

20 september 2004

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 november 2021

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

P1057
10612 (Andere identificatie: CTEP)
PACTG P1057

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .