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

2021년 10월 28일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록

300

단계

2 단계
1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 방지
할당: 무작위
중재 모델: 병렬 할당

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Allergy and Infectious Diseases (NIAID)

협력자

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

수사관

연구 의자: Myron J. Levin, MD, University of Colorado, Denver

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 완료 (실제)

2006년 1월 1일

연구 등록 날짜

최초 제출

2004년 9월 16일

QC 기준을 충족하는 최초 제출

2004년 9월 17일

처음 게시됨 (추정)

2004년 9월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 11월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 10월 28일

마지막으로 확인됨

2021년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

P1057
10612 (기타 식별자: CTEP)
PACTG P1057

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .