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

Tracking Information
First Submitted Date ICMJE	September 16, 2004
First Posted Date ICMJE	September 20, 2004
Last Update Posted Date	May 18, 2012
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00091702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
Official Title ICMJE	A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Prevention
Condition ICMJE	HIV Infections; Influenza
Intervention ICMJE	Biological: Cold-adapted live attenuated influenza vaccine (FluMist); Biological: Inactivated influenza vaccine (IAIV)
Study Arms	Not Provided
Publications *	Günthard 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.; 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.; 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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	300
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	5 Years to 17 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Puerto Rico, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00091702
Other Study ID Numbers ICMJE	P1057; 10612 ( Registry Identifier: DAIDS-ES ID ); PACTG P1057
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators ICMJE	Study Chair: Myron J. Levin, MD University of Colorado, Denver
PRS Account	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	May 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP