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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00091702
First received: September 16, 2004
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Influenza
Biological: Cold-adapted live attenuated influenza vaccine (FluMist)
Biological: Inactivated influenza vaccine (IAIV)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091702

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

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00091702     History of Changes
Other Study ID Numbers: P1057, 10612, PACTG P1057
Study First Received: September 16, 2004
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
FluMist
Influenza Vaccine
Adolescent
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014