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

NCT00091702 | Completed Phase 1

• 3 other identifiers: P105710612PACTG P1057
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 61

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.

Conditions

HIV Infections; Influenza

Keywords

FluMist; Influenza Vaccine; Adolescent; Treatment Experienced

Interventions

Cold-adapted live attenuated influenza vaccine (FluMist) BIOLOGICAL

Inactivated influenza vaccine (IAIV) BIOLOGICAL

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (61)

UAB, Dept. of Ped., Div. of Infectious Diseases

Birmingham, Alabama, 35233, United States

Location

Univ. of South Alabama College of Medicine, Southeast Ped. ACTU

Mobile, Alabama, United States

Location

Phoenix Children's Hosp.

Phoenix, Arizona, 85006, United States

Location

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, United States

Location

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, 94609-1809, United States

Location

Children's Hosp. of Orange County

Orange, California, 92868, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 92103, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 94143-0105, United States

Location

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, 90509, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, United States

Location

Connecticut Children's Med. Ctr.

Hartford, Connecticut, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06504, United States

Location

Children's National Med. Ctr. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20010, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20010, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

South Florida CDC Ft Lauderdale NICHD CRS

Fort Lauderdale, Florida, 33316, United States

Location

Children's Diagnostic & Treatment Ctr. of South Florida

Fort Lauderdale, Florida, United States

Location

Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy

Gainesville, Florida, 32610-0296, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33136, United States

Location

USF - Tampa NICHD CRS

Tampa, Florida, 33620, United States

Location

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Augusta, Georgia, United States

Location

Columbus Regional HealthCare System, The Med. Ctr.

Columbus, Georgia, 31901, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

Chicago, Illinois, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112-2699, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

Lawrence Family Health Ctr., Essex St. Clinic

Lawrence, Massachusetts, 01841-2884, United States

Location

Lowell Community Health Ctr.

Lowell, Massachusetts, 01854, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.

St Louis, Missouri, 63110, United States

Location

NJ Med. School CRS

Newark, New Jersey, United States

Location

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, 11203-2098, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases

New York, New York, 10029, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

Columbia IMPAACT CRS

New York, New York, United States

Location

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, 14642, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794-8111, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

Jacobi Med. Ctr. Bronx NICHD CRS

The Bronx, New York, 10461, United States

Location

Jacobi Med. Ctr.

The Bronx, New York, 10461, United States

Location

UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

Chapel Hill, North Carolina, 27599-7220, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27705, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 19104-4318, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105-2794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Children's Hosp. of the King's Daughters, Infectious Disease

Norfolk, Virginia, 23507, United States

Location

Seattle Children's Hospital CRS

Seattle, Washington, 98105-0371, United States

Location

UW School of Medicine - CHRMC

Seattle, Washington, 98105, United States

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936-5067, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico

Location

Related Publications (5)

• 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.

  PMID: 10669335 BACKGROUND

• 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.

  PMID: 9580647 BACKGROUND

• 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.

  PMID: 11740317 BACKGROUND

• 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.

  PMID: 10669363 BACKGROUND

• 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.

  PMID: 20581690 RESULT

MeSH Terms

Conditions

HIV Infections; Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Study Officials

• Myron J. Levin, MD

  University of Colorado, Denver

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2004
• First Posted: September 20, 2004
• Study Completion: January 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

PR (2); US (59)