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

2021年10月28日更新者：National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册

300

阶段

阶段2
阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

调查人员

学习椅：Myron J. Levin, MD、University of Colorado, Denver

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

研究完成 (实际的)

2006年1月1日

研究注册日期

首次提交

2004年9月16日

首先提交符合 QC 标准的

2004年9月17日

首次发布 (估计)

2004年9月20日

研究记录更新

最后更新发布 (实际的)

2021年11月1日

上次提交的符合 QC 标准的更新

2021年10月28日

最后验证

2021年10月1日