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

Primary Purpose

HIV Infections, Influenza

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cold-adapted live attenuated influenza vaccine (FluMist)
Inactivated influenza vaccine (IAIV)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring FluMist, Influenza Vaccine, Adolescent, Treatment Experienced

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
  • Phoenix Children's Hosp.
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • Children's Hosp. of Orange County
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Connecticut Children's Med. Ctr.
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr. Washington DC NICHD CRS
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • South Florida CDC Ft Lauderdale NICHD CRS
  • Children's Diagnostic & Treatment Ctr. of South Florida
  • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • USF - Tampa NICHD CRS
  • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Columbus Regional HealthCare System, The Med. Ctr.
  • Chicago Children's CRS
  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Lawrence Family Health Ctr., Essex St. Clinic
  • Lowell Community Health Ctr.
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Children's Hospital of Michigan NICHD CRS
  • Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
  • NJ Med. School CRS
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • Jacobi Med. Ctr. Bronx NICHD CRS
  • Jacobi Med. Ctr.
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • Nyu Ny Nichd Crs
  • Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Columbia IMPAACT CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Jude/UTHSC CRS
  • Texas Children's Hosp. CRS
  • Children's Hosp. of the King's Daughters, Infectious Disease
  • Seattle Children's Hospital CRS
  • UW School of Medicine - CHRMC
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • San Juan City Hosp. PR NICHD CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 16, 2004
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00091702
Brief Title
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Influenza
Keywords
FluMist, Influenza Vaccine, Adolescent, Treatment Experienced

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Cold-adapted live attenuated influenza vaccine (FluMist)
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine (IAIV)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron J. Levin, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Chair
Facility Information:
Facility Name
UAB, Dept. of Ped., Div. of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Phoenix Children's Hosp.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Children's Hosp. of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0105
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Connecticut Children's Med. Ctr.
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Children's National Med. Ctr. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
South Florida CDC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Children's Diagnostic & Treatment Ctr. of South Florida
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
USF - Tampa NICHD CRS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Columbus Regional HealthCare System, The Med. Ctr.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Lawrence Family Health Ctr., Essex St. Clinic
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01841-2884
Country
United States
Facility Name
Lowell Community Health Ctr.
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Jacobi Med. Ctr. Bronx NICHD CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jacobi Med. Ctr.
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203-2098
Country
United States
Facility Name
Nyu Ny Nichd Crs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hosp. of the King's Daughters, Infectious Disease
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Children's Hospital CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-0371
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
10669335
Citation
Gunthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31. doi: 10.1086/315260.
Results Reference
background
PubMed Identifier
9580647
Citation
Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998 May 14;338(20):1405-12. doi: 10.1056/NEJM199805143382002.
Results Reference
background
PubMed Identifier
11740317
Citation
King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, Newman F, Belshe RB, Kovacs A, Deville JG, Jelonek M; HIV Influenza Study Group. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J. 2001 Dec;20(12):1124-31. doi: 10.1097/00006454-200112000-00006.
Results Reference
background
PubMed Identifier
10669363
Citation
King JC Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, Lambert JS, Belshe RB. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000 Feb;181(2):725-8. doi: 10.1086/315246.
Results Reference
background
PubMed Identifier
20581690
Citation
Weinberg A, Song LY, Walker R, Allende M, Fenton T, Patterson-Bartlett J, Nachman S, Kemble G, Yi TT, Defechereux P, Wara D, Read JS, Levin M; IMPAACT P1057 Team. Anti-influenza serum and mucosal antibody responses after administration of live attenuated or inactivated influenza vaccines to HIV-infected children. J Acquir Immune Defic Syndr. 2010 Oct;55(2):189-96. doi: 10.1097/QAI.0b013e3181e46308.
Results Reference
result

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

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