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

October 28, 2021 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 16, 2004

First Submitted That Met QC Criteria

September 17, 2004

First Posted (Estimate)

September 20, 2004

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1057
  • 10612 (Other Identifier: CTEP)
  • PACTG P1057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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