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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00091702 |
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 |
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HIV Infections Influenza |
Biological: Cold-adapted live attenuated influenza vaccine (FluMist) Biological: Inactivated influenza vaccine (IAIV) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Myron J. Levin, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | PACTG P1057 |
Study First Received: | September 16, 2004 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00091702 History of Changes |
Health Authority: | United States: Federal Government |
FluMist Influenza Vaccine Adolescent Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Influenza, Human Orthomyxoviridae Infections Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Orthomyxoviridae Infections Infection Immunologic Deficiency Syndromes |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Sexually Transmitted Diseases Influenza, Human Lentivirus Infections Retroviridae Infections |